Instructions for Use Dental Implants System

XGATE Dental Implants System Instructions for Use

1.Product Description

The XGATE Dental Implants System contains a variety of types and sizes of specially designed bone-implantable titanium alloy Ti6Al4V ELI dental implants, dental abutments and dental instruments.

The XGATE Dental Implant design is a spiral tapered implant: self-drilling, self-tapping and self-condensing. XGATE Dental Implants are available in two options: (a) Conical 11° Connection Hex; (b) Internal Hex Connection.

The Dental Implants are available with two types of surface treatment: (a) Pure & Porous (P&P), consisting of hydroxyapatite and calcium phosphates sandblasting with large particles followed by acid etching; (b) SBA – Al2O3 sandblasting with large particles followed by acid etching.

Some products may not be regulatory cleared for sale in your market. Please contact your local sales representative.

XGATE Dental Implants Conical 11° Connection Hex

Platform	Implant diameter	Length
Slim	Ø 3.0 mm	10, 11.5, 13, 15 mm
MP	Ø 3.3 mm	8, 10, 11.5, 13, 16 mm
RP	Ø 3.75 mm	8, 10, 11.5, 13, 16 mm
RP	Ø 4.2 mm	8, 10, 11.5, 13, 16 mm
RP	Ø 5.0 mm	8, 10, 11.5, 13, 16 mm

XGATE Dental Implants Internal Hex Connection

Platform	Implant diameter	Length
RP	Ø 3.3 mm	8, 10, 11.5, 13, 16 mm
RP	Ø 3.75 mm	8, 10, 11.5, 13, 16 mm
RP	Ø 4.2 mm	8, 10, 11.5, 13, 16 mm
RP	Ø 5.0 mm	8, 10, 11.5, 13, 16 mm

Note: Dental Implants are provided sterile, for single use, with a cover screw. Package opening instructions and the related dental instruments involved in the surgical procedure (e.g. dental drills, depth probe, implant driver, screwdriver, ratchet) as well as the drilling protocol are described in the XGATE Surgical & Prosthetic Manual TF-MDR-1000-17.3. For processing of reusable dental surgical instruments, refer to IFU TF-MDR-2000-17.1.

2.Intended Use

XGATE dental implants can be used for all indications requiring oral, endosseous implants for functional and aesthetic rehabilitation of edentulous and partially dentate upper or lower jaws. The restoration may comprise single crowns, bridges and partial or full dentures connected to the implants with abutments.

3.Intended Users and Patient Groups

XGATE medical devices are intended to be used by dental healthcare professionals.

XGATE medical devices are intended to be used in partially and/or fully edentulous patients subject to dental implantation and/or restoration treatment.

4.Indication for Use

The XGATE Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore the patient's chewing function. The XGATE Dental Implants System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Conical Slim implants (Ø3.0 mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central incisor, mandibular lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, to restore the patient's chewing function. Mandibular central and lateral incisors must be splinted if two or more narrow implants are used adjacent to one another.

5.Materials

XGATE Dental Implants: titanium alloy Ti-6Al-4V, Al2O3, hydroxyapatite and calcium phosphates.

6.Contraindications

The Dental Implants System is contraindicated for:

• Patients allergic, intolerant or hypersensitive to titanium Ti-6Al-4V (titanium, aluminum, vanadium) or stainless steel (surgical instruments; dental drills are with or without DLC – diamond-like carbon – coating).
• Patients medically unfit for operation and/or surgical procedures: severe uncontrollable systemic disease, metabolic bone disorders, uncontrolled hemorrhagic diseases, uncooperative/unmotivated patient, drug, alcohol or tobacco abuse, psychotic diseases, long-standing therapy-resistant functional disturbances, xerostomia, compromised immunoresistance and leucocytic malfunctioning, illnesses requiring periodic administration of steroids or anticonvulsants, uncontrollable endocrine diseases.

Relative contraindications: previous bone radiotherapy, diabetes mellitus, medicinal anticoagulation / hemorrhagic diatheses, bruxism, parafunctional habits, complicated anatomical bone conditions, uncontrolled periodontitis, diseases of the temporomandibular joint, treatable pathological diseases of the jaw and mucous membranes, pregnancy, inadequate oral hygiene.

Local contraindications: insufficient bone and inadequate bone quality, local root debris, or the location of vital blood vessels, nerves, maxillary sinus and soft tissue space and their relation to implant placement.

7.Warning

XGATE dental medical devices are intended for use by trained dental specialists.

It is recommended that practitioners attend hands-on training courses in order to learn proper techniques, including biomechanical requirements and radiographic evaluation.

To achieve the desired performance, XGATE medical devices must be used in accordance with the XGATE Surgical & Prosthetic Manual (TF-MDR-1000-17.3) and IFU Dental Surgical Instruments Reusable (TF-MDR-2000-17.1).

Dental Implants are provided sterile and are for single use. Do not re-sterilize and do not re-use! The implant is sterile unless the package is opened or damaged. Do not use the product if the packaging has been damaged or previously opened!

Dental Abutments, Healing Caps and Screws are provided non-sterile and for single use; they must be sterilized before use in accordance with IFU TF-MDR-1000-17.2.

Use of a non-sterile device may lead to infection of tissues or infectious diseases.

For small devices, components and detachable devices, care must be taken that they are not swallowed or aspirated by the patient. Use supporting medical devices to prevent aspiration or swallowing, e.g. a throat shield.

Deficiencies in patient evaluation, pre-operative diagnosis and treatment planning may cause implant failure or patient injury.

Drilling beyond the intended depth in lower jaw surgery may potentially result in permanent numbness of the lower lip and chin or lead to hemorrhage in the floor of the mouth.

Periodic follow-up evaluations including radiographs are recommended. Special attention should be paid to oral hygiene and habits, occlusion adjustments and the stability of the prosthesis.

8.Precautions

Thorough screening of prospective implant candidates must be performed. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, periodontal status and adequacy of bone. Lateral cephalometric radiographs, CT scans and tomograms may also be beneficial.

Special attention has to be given to patients who have localized or systemic factors that could interfere with the healing process of either bone or soft tissue or with the osseointegration process (e.g. evaluation of the dentition, cigarette smoking, poor oral hygiene, uncontrolled diabetes, oro-facial radiotherapy, steroid therapy, infections in the neighboring bone). Special caution is advised in patients who receive bisphosphonate therapy.

In general, implant placement and prosthetic design must accommodate individual patient conditions. In case of bruxism or unfavorable jaw relationships, reappraisal of the treatment option may be considered.

Use of the implant may require preoperative antibiotic prophylaxis. In type I or II bone, when you feel a strong resistance while placing the implant, remove the mount and place the 2.5 mm insertion tool, rotate back (counterclockwise) 2–3 turns, then continue to screw clockwise. Small-diameter implants and angled abutments are not recommended for use in the posterior region of the mouth. The maximum insertion torque is 50 Ncm.

9.Adverse Effects

Loss of implant anchorage (failure to osseointegrate) and loss of the prosthesis are possible occurrences after surgery. Lack of quantity or quality of the remaining bone, infections, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are some potential causes of loss of anchorage.

10.Surgical Procedure

Surgical procedures and the drilling protocol are described in the XGATE Surgical & Prosthetic Manual (TF-MDR-1000-17.3).

Tightening limit recommendations

• Implant installation to the desired position: maximum insertion torque 50 Ncm. Do not exceed 50 Ncm.
• For immediate function, the implant should be able to withstand a final torque of 35–45 Ncm.
• Tightening of the healing abutment on the implant: 5–10 Ncm.
• Tightening of the abutment screw on the implant analog: 10–15 Ncm.
• Tightening of the abutment screw on the implant: 30–35 Ncm.

11.Clinical Benefits and Undesirable Side Effects

Clinical benefits associated with the XGATE Dental Implants System and Instruments

The XGATE Dental Implants System consists of implants, abutments, screws, accessories and instruments used in surgical implantation procedures and restorative applications. The clinical benefits arising from these procedures are restoring missing teeth, restoring missing crowns and restoring the patient's chewing function.

Undesirable side effects associated with the XGATE Dental Implants System and Instruments

The surgical implantation procedure involves risks which may be associated with typical side effects such as localized swelling, infection, inflammation, tenderness of short duration, edema and hematoma or bleeding. Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Although it is most probably of a temporary nature, in very rare cases the numbness has been permanent. Gingival-mucosal (gum tissue) ulceration, tissue reaction or infection may occur but generally respond to local care.

Complications associated with dental implants include, but are not limited to: temporary complaints such as pain, swelling, speech impediments, gingival infections, inadequate function or device failure (mobility, loss of integrity), injury during surgery, bone fracture, perforation (sinus, alveolar plates), post-surgical paresthesia.

Complications associated with dental abutments include, but are not limited to: inadequate function (incompatibility), device failure (mobility, loss of integrity), damage to existing dentition.

During the use of dental surgical instruments and implantation, the pharyngeal (gag) reflex may be triggered in patients with a sensitive gag reflex.

Longer-term complaints: chronic pain related to the dental implant, permanent paresthesia, dysesthesia, loss of bone in the upper/lower ridges, damage to existing dentition, local or systemic infections including bacterial endocarditis, oroantral fistulae, oronasal fistulae, discoloration in the mucosal area, adversely affected adjacent teeth, irreversible injury to adjacent teeth, fractured implant, jaw, bone or restoration, aesthetic problems, nerve damage, exfoliation, hyperplasia.

In accordance with the requirements of the European Medical Device Regulation MDR (EU) 2017/745, the XGATE Summary of Safety and Clinical Performance (SSCP) for XGATE Dental Implants & Abutments is available at the following website:

https://ec.europa.eu/tools/eudamed

(The website will be available upon launch of the European Database on Medical Devices, EUDAMED.)

Serious Incident Notice

For a user/patient/third party in the European Union and in countries with identical regulatory requirements: if a serious incident has occurred during use of this device or as a result of its use, please report it to the manufacturer and to your national authority.

12.Magnetic Resonance Imaging (MRI) – Safety Information

The XGATE Dental Implants System has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration or image artifact in the MR environment. The safety of the XGATE Dental Implants System in the MR environment is unknown. Scanning a patient who has this device may result in patient injury.

13.Storage, Handling and Transportation

The products must be stored in dry conditions in their original packaging at room temperature and must not be exposed to direct sunlight. Incorrect storage and transportation may influence device characteristics, leading to failure.

14.Disposal

Product disposal shall be in accordance with local regulations and environmental requirements, considering different contamination levels.

Manufacturer: Xgate Dental Group GmbH
Falkensteiner Straße 77, 60322 Frankfurt am Main, Germany
Tel.: +49 69 95 90 840-0 · xgate.dental

Distributor: XGATE Dental Inc
24A Trolley Square Unit #4038, Wilmington, DE 19806, USA
Tel.: (302) 498-8373 · www.XGATE.Dental

1282

Prescription device: Rx only
Caution: Federal law restricts this device to sale by or on the order of a licensed physician or dentist.

Basic UDI-DI Information

Product	Basic UDI-DI number
Dental Implants	42558958XGImplantB4

Implant Card

XGATE Dental Implants are provided with an Implant Card which contains important information for patients regarding the device. Complete the Implant Card by filling in the patient and device identification information as indicated and provide the completed Implant Card to the patient.

All rights reserved

XGATE Dental logos and all other trade names and trademarks used in this document are trademarks of XGATE Dental.

Any indication of trade names and/or trademarks of third-party dental implant companies, such as OSSTEM®, Nobel Biocare®, Nobel Active®, Megagen® AnyRidge, MIS®, Straumann®, Neodent® Grand Morse, Megagen AnyOne and Astra®, remains subject to their registered trade name and trademark rights. XGATE Dental does not own or claim rights to third-party trade names.

Symbols Glossary

The following symbols may be presented on the device labeling and/or accompanying information.

Catalogue number

Lot number

Use-by date

Do not use if package is damaged and consult instructions for use

Consult instructions for use or consult electronic instructions for use

Caution

Manufacturer details

Authorized representative in the European Community

CE mark

Medical device

Rx only

Caution: Federal law restricts this device to sale by or on the order of a physician or dentist.

Unique Device Identifier

Date of manufacture

Non-pyrogenic

Sterilized using irradiation

Non-sterile

Do not resterilize

Do not re-use

Single sterile barrier system

Double sterile barrier system

Single sterile barrier system with protective packaging inside

Single sterile barrier system with protective packaging outside

Keep away from sunlight

Keep dry

Temperature limit

Humidity limitation – standard ambient conditions

Date

Information website for patients

Patient name or patient ID

Name and address of the implanting healthcare institution/provider