STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM

K023580 · Sterngold · DZE · Jan 17, 2003 · Dental

Device Facts

• Record ID: K023580
• Device Name: STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM
• Applicant: Sterngold
• Product Code: DZE · Dental
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated: · For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis · For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis · For single tooth or multiple unit prosthesis

Device Story

Endosseous dental implant system; root-form, external-hex, self-tapping, double-threaded design. Manufactured from pure, implant-grade titanium. External surface (excluding neck/head) acid-etched to create roughened microsurface for osseointegration. Used by dental clinicians in clinical settings for surgical implantation into jawbone to support dental prostheses. Compatible with standard external-hex abutments. Includes cover screw; SternTwist internal grip insertion tool available as accessory.

Clinical Evidence

Bench testing only. Conformity demonstrated with FDA guidance documents: 'Overview of Information Necessary for Premarket Notification Submissions for Endosseous Implants' and 'Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants'.

Technological Characteristics

Material: pure, implant-grade titanium. Design: root-form, external-hex, self-tapping, double-threaded. Surface: acid-etched. Dimensions: diameters 3.75mm, 4.00mm, 5.00mm; lengths 8.5mm to 18mm. Connectivity: compatible with standard external-hex abutments. Sterilization: not specified.

Indications for Use

Indicated for patients requiring dental prostheses in fully or partially edentulous maxilla or mandible; supports single or multiple unit removable or fixed prostheses.

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

• Implant Innovations Osseotite Dental Implant System
• Nobel Biocare MKIII Dental Implant System

Submission Summary (Full Text)

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K023580

October 21, 2002 Acid Etch Dental Implant System

# 510(k) Summary

| Trade Name: | Sterngold Acid Etch Dental Implant System | JAN 1 7 2003 |
|----------------------|-----------------------------------------------------------------------------------------------------------------|--------------|
| Sponsor: | Sterngold<br>23 Frank Mossberg Drive<br>Attleboro, MA 02703 | |
| Device Generic Name: | Dental endosseous implant system | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class III | |
| Product Code: | DZE (21CFR872.3640) | |

### Predicate Devices:

The Sterngold Acid Etch Dental Implants are substantially equivalent to other currently marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process, including the Implant Innovations Osseotite Dental Implant System and the Nobel Biocare MKIII Dental Implant System.

### Product Description:

The Sterngold Acid Etch Dental Implant System consists of standard, external-hex, self-tapping, doublethreaded. root-form endosseous implants that will be available is a variety of sizes to suit individual user/patient needs. Each implant is provided with a cover screw. The implants are manufactured from pure, implant-grade titanium. The external surface of the implants (excluding the top three threads, the neck and the implant head) is lightly acid etched to remove any traces of contaminants remaining from the manufacturing process, and to achieve a slightly roughened microsurface to aid in implant osseointegration.

The proposed implants are compatible with standard, regular platform (4.1mm), external-hex (antirotational) abutments such as the currently marketed Sterngold-Implant Innovations, and Branemark System (Nobel Biocare). A specially-designed SternTwist internal grip insertion tool will be available as an accessory to the Acid Etch Implants.

The Sterngold Acid Etch Implants will be available in the following sizes:

| Diameter (mm) | Overall Length (mm) |
|---------------|---------------------------|
| 3.75 | 8.5, 10, 11.5, 13, 15, 18 |
| 4.00 | 8.5, 10, 13, 15 |
| 5.00 | 8.5, 10 |

### Indications for Use:

The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated:

· For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis

· For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis

· For single tooth or multiple unit prosthesis

### Safety and Performance:

This submission is an Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket

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Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with the following standards:

- Overview of Information Necessary for Premarket Notification Submissions for Endosseous . Implants (FDA Guidance)
- . Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants (FDA Guidance; December 9, 1996)

## Conclusion:

Based on their indications for use, technological characteristics, and comparison to predicate devices, the Sterngold Acid Etch Dental Implant System has been shown to be safe and effective for the product's intended use.

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JAN 1 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Sterngold C/O Ms. Pamela Papineau Delphi Medical Consulting, Incorporated 5 Whitcomb Avenue Aver, Massachusetts 01432

Re: K023580

Trade/Device Name: Sterngold Acid Etch Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant System Regulatory Class: III Product Code: DZE Dated: October 21, 2002 Received: October 24, 2002

Dear Ms. Papineau:

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 such 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 - Ms. Papineau

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Timothy A. Ulatowski 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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Page

510(k) Number (if known): K023580

Sterngold Acid Etch Dental Implant System Device Name:

Indications for Use:

The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated:

· For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis

- · For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis
· For single tooth or multiple unit prosthesis

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻠﮯ Prescription Use (Per 21 CFR 801.109)

OR

Over-the -Counter Use

Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K022380

000008