ERA IMPLANT

K021045 · Sterngold · DZE · Jun 26, 2002 · Dental

Device Facts

• Record ID: K021045
• Device Name: ERA IMPLANT
• Applicant: Sterngold
• Product Code: DZE · Dental
• Decision Date: Jun 26, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ERA Implant is intended for surgical placement in edentulous anterior regions of the maxiliary arch to provide temporary support and permit immediate and ongoing fixation of new or existing crown and bridge applications, for full or partial dentures, with minimal invasive surgical intervention. The ERA Implant is indicated for use as a temporary, when placed between traditional implants to stabilize a denture during healing period.

Device Story

Titanium alloy threaded screw; temporary endosseous dental implant. Used to stabilize dentures between traditional implants during healing; restores chewing function. Available in 2.2 mm diameter; lengths 10, 13, 15 mm. Two head designs: ERA abutment interface (1.2, 3, 4 mm cuff heights; 0°, 5°, 11°, 17° angles) and non-angled (0.76, 2, 3, 4 mm cuff heights). Installed by physicians via surgical procedure. Provides temporary restorative solution; enables immediate fixation of crown/bridge applications. Benefits patient by providing stability during conventional implantation therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy threaded screw. Dimensions: 2.2 mm diameter; 10, 13, 15 mm lengths. Features ERA abutment interface or non-angled head designs with varying cuff heights and angulations. Mechanical fixation device.

Indications for Use

Indicated for use as a temporary support in edentulous anterior regions of the maxillary arch to stabilize dentures during the healing period and restore chewing function for patients undergoing conventional implantation therapy.

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.

Submission Summary (Full Text)

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K02/645

## 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Sterngold is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Sterngold chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

| Trade Name: | ERA Implant |
|----------------------|---------------------------|
| Sponsor: | Sterngold |
| | 23 Frank Mossberg Drive |
| | P.O. Box 2967 |
| | Attleboro, MA 02703-0967 |
| | Registration #2921595 |
| Device Generic Name: | Endosseous Dental Implant |

**Device Generic Name:** Endosseous Dental Implant

According to Section 513 of the Federal Food, Drug, and Classification: Cosmetic Act, the device classification is Class III.

## Predicate Devices: Refer to Attachment C Manufactured by: Refer to Attachment C

Product Description: The Sterngold ERA Implant is a titanium Alloy threaded screw intended to have a simpler and quicker installation procedure than is currently used for conventional implants. This design will enable the physician to quickly and efficiently establish an inexpensive temporary restorative solution to patients undergoing longer-term. conventional implantation therapy.

The Sterngold ERA Implant is available in 2.2 mm diameter and lengths of 10 mm. 13 mm. and 15 mm. The head features two designs - One implant featuring our ERA abutment interface with 1.2mm. 3mm. 4mm cuff heights and offers a 0°, 5°, 11°, and 17° angle abutments. The second implant with cuff heights of .76mm, 2mm, 3mm, and 4mm with no angles.

Indications for Use: The ERA Implant is indicated for Use as a temporary support, when placed between traditional implants to stabilize a denture during healing period, and to restore the patient's chewing function.

## Safety and Performance:

This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications." In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Premarket Notification 510(k); Regulatory Requirements for Medical Devices.

Conclusion: Based on the indications for use, technological characteristics, and comparison to predicate devices, the ERA Implant has been shown to be safe and effective for its intended use.

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Public Health Service

Image /page/1/Picture/2 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, layered on top of each other, with flowing lines suggesting hair or fabric below the faces.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Maria Rao Quality and Regulatory Manager Sterngold 23 Frank Mossberg Drive Attleboro, Massachusetts 02703-0967

Re: K021045

Trade/Device Name: ERA Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: March 25, 2002 Received: April 1, 2002

Dear Ms. Rao:

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.

JUN 2 6 2002

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 vour 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.

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.

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Page 2 - Ms. Rao

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 (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.

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Sterngold 510k Premarket Notification

Page 1 of

510(k) Number (if known): _ 长۵2/045

ERA Implant Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The ERA Implant is intended for surgical placement in edentulous anterior regions of the Hic Ervi infigure is moulary arch to provide temporary support and permit immediate maxiliary and ongoing fixation of new or existing crown and bridge applications, for full or partial dentures, with minimal invasive surgical intervention.

purtial contained in indicated for use as a temporary, when placed between traditional implants to stabilize a denture during healing period.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use

Suna Rover
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number. K021005