SEAL & PROTECT™ DENTAL VARNISH is a protective sealant for exposed dentine. The Indications for Use are: (1) Reduction of abrasion and erosion of exposed cervical dentine; and (2) Treatment of hypersensitive cervical areas.

Device Description

SEAL & PROTECT™ DENTAL VARNISH is a nanofilied light-curing dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.

AI/ML Overview

This submission describes SEAL & PROTECT™ DENTAL VARNISH, a nanofilled light-curing dental varnish. The primary claim of the device is its safety and effectiveness.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Goal)	Reported Device Performance (as demonstrated in the study)
Absence of cytotoxicity	The device was evaluated for cytotoxicity (L929). The conclusion indicates "no evidence of any hazardous effects to the patient if the product is used as directed."
Absence of mutagenicity	The device was evaluated for mutagenicity (Ames Test). The conclusion indicates "no evidence of any hazardous effects to the patient if the product is used as directed."
Safety regarding migration of constituents	"The possibility of migration of constituents occurring during the application and polymerization phase cannot be absolutely ruled out. However, in light of the low volume of material applied, the low solubility in physiological liquids and the inert properties of the polymerized synthetic matrix, the amount and type of the substances temporarily released from the product must be considered as harmless." (This is a qualitative risk assessment rather than a quantitative performance metric).
Equivalence to predicate devices (Prime & Bond® NT™ Universal Dental Adhesive K982394)	The submission states, "We believe that the prior use of the components of SEAL & PROTECT™ DENTAL VARNISH in legally marketed devices, the results of biocompatibility testing, and the performance data support the safety and effectiveness of SEAL & PROTECT™ DENTAL VARNISH for the indicated uses." The FDA's substantial equivalence letter confirms this, stating the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly mentioned in terms of subject or clinical data. The testing described (cytotoxicity and mutagenicity) refers to laboratory tests.
Data Provenance: Not specified. The biocompatibility tests (L929 toxicity and Ames Test) are commonly in-vitro laboratory tests and typically do not involve human subjects or specific country data provenance in this context. They are likely conducted in a lab setting. It is not specified if the data is retrospective or prospective, but given the nature of the tests, they would be experimental.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The ground truth for the cytotoxicity and mutagenicity tests would be based on established scientific protocols and interpretation by qualified toxicologists or biologists, but specifics are absent.

4. Adjudication Method for the Test Set

This information is not provided. Adjudication methods like 2+1 or 3+1 are typical for clinical trials where multiple experts assess outcomes. For in-vitro biocompatibility tests, the interpretation typically relies on a single, qualified expert following established scientific guidelines.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on biocompatibility and general safety, and substantial equivalence to a predicate device, rather than comparing human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a dental varnish, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable.

7. The Type of Ground Truth Used

The ground truth used for the reported performance (cytotoxicity, mutagenicity, and safety assessment) is based on:

Standardized in-vitro biocompatibility tests: L929 cell culture for cytotoxicity and Ames Test for mutagenicity, which have defined positive and negative controls and interpretation criteria.
Expert qualitative assessment: For the migration of constituents, a qualitative assessment by DENTSPLY experts concluded the amount and type of temporarily released substances were "harmless" based on material properties and application volume.
Predicate device equivalence: Implied safety and effectiveness grounded in the regulatory history and proven performance of the designated predicate device (Prime & Bond® NT™ Universal Dental Adhesive).

8. The Sample Size for the Training Set

N/A. This device is not an AI/ML algorithm that requires a training set. The "training" for this product would be its formulation and development based on established dental material science principles.

9. How the Ground Truth for the Training Set Was Established

N/A. As this is not an AI/ML algorithm, there is no "training set" or ground truth established for it in that context. The "ground truth" for the material's properties and intended function would have been established through extensive research and development in dental materials science.

Summary

{0}------------------------------------------------

NOV 1 7 1999

510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

DENTSPLY International

570 West College Avenue P.O. Box 872 York, PA 17405-0872 17171 845-7511 Fox (717) 854-2343

P. J. Lehn Telefax (717) 849-4343

P. Jeffery Lehn CONTACT:

DATE PREPARED:

TRADE OR PROPRIETARY NAME:	SEAL & PROTECT TM DENTAL VARNISH
CLASSIFICATION NAME:	cavity varnish 872.3260
PREDICATE DEVICES:	Prime & Bond ® NT TM Universal Dental Adhesive K982394

DEVICE DESCRIPTION: SEAL & PROTECT™ DENTAL VARNISH is a nanofilied light-curing dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.

INTENDED USE: SEAL & PROTECT™ DENTAL VARNISH is a protective sealant for exposed dentine. The Indications for Use are: (1) Reduction of abrasion and erosion of exposed cervical dentine; and (2) Treatment of hypersensitive cervical areas.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in SEAL & PROTECT™ DENTAL VARNISH have been used in legally marketed devices.

SEAL & PROTECT™ DENTAL VARNISH was evaluated for cytotoxicity (L929) and mutagenicity (Ames Test). The conclusions indicate that there is no evidence of any hazardous effects to the patient if the product is used as directed. The possibility of migration of constituents occurring during the application and polymerization phase cannot be absolutely ruled out, However, in light of the low volume of material applied, the low solubility in physiological liquids and the inert properties of the polymerized synthetic matrix, the amount and type of the substances temporarily released from the product must be considered as harmless.

We believe that the prior use of the components of SEAL & PROTECT™ DENTAL VARNISH in legally marketed devices, the results of biocompatibility testing, and the performance data support the safety and effectiveness of SEAL & PROTECT™ DENTAL VARNISH for the indicated uses.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-headed serpent entwined around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Public Health Service

6 2007 DEC

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Helen Lewis Director, Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, Pennsylvania 17405

Re: K992822

Trade/Device Name: Seal & Protect™ Dental Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 20, 1999 Received: August 23, 1999

Dear Ms. Lewis:

This letter corrects our substantially equivalent letter of November 1994 999 and 1995 is

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 (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.

1982 1988.

{2}------------------------------------------------

Page 2 - Ms. Lewis

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 continue 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sufte Y. Michael Davis

Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

PREMARKET NOTIFICATION

INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

Y ga 280

SEAL & PROTECT™ DENTAL VARNISH Device Name: _________________________________________________________________________________________________________________________________________________________________

SEAL & PROTECT™ DENTAL VARNISH is a protective sealant for exposed dentine. The

Indications for Use are:

Reduction of abrasion and erosion of exposed cervical dentine 器
Treatment of hypersensitive cervical areas �

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ V

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

REVISED November 12, 1999

0000009

Regulation Number and Section

§ 872.3260 Cavity varnish.

(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.