STERNVANTAGE VARNISH LC, MODEL 221001

K984341 · Sterngold/Implamed · EBI · Jan 8, 1999 · Dental

Device Facts

• Record ID: K984341
• Device Name: STERNVANTAGE VARNISH LC, MODEL 221001
• Applicant: Sterngold/Implamed
• Product Code: EBI · Dental
• Decision Date: Jan 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.

Device Story

SternVantage Varnish LC is a single-component, acrylate-based, light-curing surface coating material. Used by dental professionals to seal and finish polymerized composite surfaces, denture bases, and temporary crowns and bridges. Applied to dental restorations to provide a protective surface finish; cured via light activation. No complex processing or electronic components involved.

Clinical Evidence

No clinical data provided; substantial equivalence based solely on design and performance characteristics.

Technological Characteristics

Single-component, acrylate-based, light-curing dental resin. Formulated as a surface coating/sealant for dental restorations.

Indications for Use

Indicated for surface sealing and finishing of polymerized composite surfaces, denture bases, and temporary crowns and bridges in dental patients.

Regulatory Classification

Identification

A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.

Predicate Devices

• Palaseal (K892452)

Submission Summary (Full Text)

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Sterngold ImplaMed 510(k) Premarket Notification

8 - 1999 JAN

**December 2, 1998**
**SternVantage Varnish LC**

00040

K984341

# 510(k) Summary

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Trade Name:

Sponsor:

Sterngold ImplaMed 23 Frank Mossberg Drive P.O. Box 2967 Attleboro, MA 02703-0967 Registration #2921595

SternVantage Varnish LC

Denture relining, repairing and rebasing resin Device Generic Name:

Classification:

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

Predicate Devices: The proposed Stern Vantage LC is substantially equivalent to the Palaseal material marketed by Kulzer, Inc. which was cleared for marketing by FDA in K892452.

### Product Description:

The Stern Vantage Varnish LC material is a single-component, acrylate-based, light-curing surface coating material for dental applications.

### Indications for Use:

Stern Vantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.

## Safety and Performance:

Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Varnish LC are equivalent to those of the predicate device.

#### Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Vantage Varnish LC has been shown to be safe and effective for its intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 JAN

Mr. Gordon Nelson Director Sterngold ImplaMed 23 Frank Mossberg Drive P.O. Box 2967 02703-0967 Attleboro, Massachusetts

K984341 Re : SternVantage Varnish LC, Model 221001 Trade Name: Requlatory Class: II Product Code: EBI 2, 1998 Dated: December December 4, 1998 Received:

Dear Mr. Nelson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Nelson

This letter will allow you to begin marketing your device as described in your 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 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 ene regaracion onesion" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Directbr 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 ImplaMed 510(k) Premarket Notification

Page 1 of

510(k) Number (if known): K984341

Device Name: SternVantage Varnish LC

Indications for Use:

SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UseD (Per 21 CFR 801.109)

OR

Over-the -Counter Use

SwartRumn

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