OSSEOLINK DENTAL IMPLANT SYSTEM

K091878 · Global Implant Solutions, LLC · DZE · Oct 6, 2009 · Dental

Device Facts

• Record ID: K091878
• Device Name: OSSEOLINK DENTAL IMPLANT SYSTEM
• Applicant: Global Implant Solutions, LLC
• Product Code: DZE · Dental
• Decision Date: Oct 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Implants OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended. Prosthetic Abutments, Cover Screws & Healing Abutments OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.

Device Story

OsseoLink Dental Implant System consists of endosseous implants, prosthetic abutments, cover screws, and healing abutments. Used in prosthetic dentistry to support tooth restorations. Implants placed surgically in maxilla or mandible; supports single/multiple-unit restorations, cemented/screw-retained prostheses, or overdentures. System supports two-stage surgical protocols (submerged healing) or single-stage protocols (non-submerged). Immediate loading permitted given sufficient primary stability and occlusal load. Operated by dental professionals in clinical settings. Provides stable foundation for prosthetic teeth, restoring oral function and aesthetics for edentulous patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Endosseous root-form dental implants and associated abutments. System includes cover screws and healing abutments for two-stage or single-stage surgical protocols. Materials and dimensions are consistent with standard endosseous dental implant designs.

Indications for Use

Indicated for partially or fully edentulous adult patients requiring dental restoration in the maxilla or mandible. Supports single or multiple-unit restorations, including cemented, screw-retained, or overdenture prostheses, and fixed bridgework. Contraindicated for Ø 3.5 mm diameter implants in the molar region.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Suizer Dental, Inc. -- Screw Vent & Tapered Screw Vent -- (K013227)
• Nobel Biocare, LLC Groovy Implants (K050258)

Submission Summary (Full Text)

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K091878

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# SECTION 5 - 510(k) SUMMARY

## Submission Correspondent

Emergo Group, Inc.

www.emergogroup.com/

OCT - 6 2009

1705 S. Capital of Texas Hwy Suite 500 Austin, TX 78746

## Phone

Address

[phone]

## Fax

[phone]

#### Contact

Stuart R. Goldman

## Submission Sponsor

Global Implant Solutions, LLC 41 North Road Suite 207 Bedford, MA 01730 Tel: [phone] Fax: [phone]

### www.osseolink.com/

### Date Prepared

May 11, 2009

#### Trade Name

OsseoLink Dental Implant System

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## Regulation Name(s)

- 1. Endosseous Dental Implant
- 2. Endosseous Dental Implant Abutment

## Regulation Number(s)

1. 872.3640

2. 872.3630

## Classification Name(s)

1. Implant, Endosseous, Root-Form

2. Abutment, Implant, Dental, Endosseous

## Product Code(s)

1. DZE

2. NHA

# Classification Panel

Dental Devices

## Regulatory Class

Class II

## Device Description

The OsseoLink Dental Implant System is an endosseous type artificial tooth replacement system that is intended for use in prosthetic dentistry to support restorations that resemble a tooth or group of teeth.

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#### Intended Use

#### Implants

OsseoLink dental implants are indicated for use in partially or fully edentulous

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mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended.

291878

## Prosthetic Abutments, Cover Screws & Healing Abutments

OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.

### Predicate Device(s)

- 1. Suizer Dental, Inc. -- Screw Vent & Tapered Screw Vent -- (K013227)
- 2. Nobel Biocare, LLC Groovy Implants (K050258)

## Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is as safe and effective as the predicate device, and that the new device does not raise different questions regarding safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the OsseoLink Dental Implant System and the predicate devices do not raise any questions regarding its safety and effectiveness. The OsseoLink system, as designed and manufactured, is as safe and effective as the predicate devices and therefore is determined to be substantially equivalent to the referenced predicate devices.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

Global Implant Solutions, L.L.C. C/O Mr. Stuart R. Goldman Emergo Group, Incorporation 1705 South Capital of Texas Highway, Suite 500 Austin, Texas 78746

OCT - 6 2009

Re: K091878

Trade/Device Name: OsseoLink Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 21, 2009 Received: September 23, 2009

Dear Mr. Goldman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2- Mr. Goldman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

for

Susan Runner, D.D.S., M.A. Acting Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K091878

# SECTION 4 - INDICATIONS FOR USE

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510(k) Number (if known): _

## Device Name

OsseoLink Dental Implant System

#### Indications for Use

#### Implants

OsseoLink dental implants are indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The OsseoLink Dental System is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. The placement of individual Ø 3.5 mm diameter implants in the molar region in not recommended.

# Prosthetic Abutments, Cover Screws & Healing Abutments

OsseoLink prosthetic abutments are intended for use with OsseoLink dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. OsseoLink cover screws are used when submerged healing is desired in two stage implant surgery procedures. OsseoLink healing abutments are used at the time of implant placement when non-submerged (i.e., single-stage) surgical placement is indicated or following the uncovering of an implant when the two-stage protocol is followed.

| Prescription Use | _X_ |
|-----------------------------|-----|
| (Part 21 CFR 801 Subpart D) | |

Over-The-Counter Use_ AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page of

Kein Muelly for MSR
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091878