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

Device Description

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

AI/ML Overview

The provided PMA (Premarket Approval) documentation for SternVantage Varnish LC explicitly states that no performance or safety data was included in the premarket notification. Therefore, this device did not undergo a study to demonstrate it met acceptance criteria in the traditional sense of a clinical trial or performance validation study.

Instead, the device's approval was based solely on its substantial equivalence to a predicate device (Palaseal material marketed by Kulzer, Inc.) concerning its design and performance characteristics.

Given this, I cannot provide the requested information in the format for a device that underwent performance testing against acceptance criteria. However, I can explain why I cannot and what information is available based on the provided text.

Here's the breakdown of why the requested information cannot be fully provided:

No Acceptance Criteria or Reported Device Performance: The document clearly states, "Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification." This means there were no defined acceptance criteria for a new study, and no performance metrics from a new study to report. The acceptance was based on the assumption that if the new device has similar characteristics to an already-approved predicate device, it meets an equivalent standard.

Therefore, many parts of your request for information about a study proving acceptance criteria cannot be fulfilled directly from this document.

However, I can extract the relevant information from the document to explain the approval context:

Reason for Approval: Substantial Equivalence to a Predicate Device
Predicate Device: Palaseal material marketed by Kulzer, Inc. (cleared for marketing by FDA in K892452).

Since no new study demonstrating performance against acceptance criteria was conducted for SternVantage Varnish LC as part of this 510(k) submission, the following information is not available in the provided documents:

A table of acceptance criteria and the reported device performance: Not applicable, as no performance study was conducted.
Sample sized used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable (this is a dental varnish, not an AI diagnostic device).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, the Sterngold ImplaMed SternVantage Varnish LC was cleared for marketing based on its "substantial equivalence" to an existing, legally marketed predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Summary

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Sterngold ImplaMed 510(k) Premarket Notification

8 - 1999 JAN

December 2, 1998
SternVantage Varnish LC

00040

K984341

510(k) Summary

్రాలు ప్రస్తుం


	ﻴﺔ

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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription UseD (Per 21 CFR 801.109)

Over-the -Counter Use

SwartRumn

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

Regulation Number and Section

§ 872.3760 Denture relining, repairing, or rebasing resin.

(a)
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.(b)
Classification. Class II.