SEAL & PROTECT PROTECTIVE SEALANT

K021805 · Dentsply Intl. · LBH · Aug 19, 2002 · Dental

Device Facts

• Record ID: K021805
• Device Name: SEAL & PROTECT PROTECTIVE SEALANT
• Applicant: Dentsply Intl.
• Product Code: LBH · Dental
• Decision Date: Aug 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Seal & Protect™ Protective Sealant 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 Story

Seal & Protect™ Protective Sealant is a nanofilled, light-curing dental varnish. It is applied to exposed dentine surfaces to provide mechanical protection and antimicrobial action. Used by dental professionals in a clinical setting to treat cervical hypersensitivity and reduce abrasion/erosion. The device is applied topically and cured with a dental light source.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological identity to the predicate device.

Technological Characteristics

Nanofilled light-curing dental varnish. Identical to predicate K992822.

Indications for Use

Indicated for patients with exposed cervical dentine requiring reduction of abrasion/erosion or treatment of hypersensitive cervical areas.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Seal & Protect™ Protective Varnish (K992822)

Submission Summary (Full Text)

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AUG 1 9 2002

## 510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

st College Avenue 7105-0877

6 >1805

P. J. Lehn Telefax [phone]

| CONTACT: | P. Jeffery Lehn |
|----------------------------|---------------------------------------------------------|
| DATE PREPARED: | May 31, 2002 |
| TRADE OR PROPRIETARY NAME: | Seal & Protect ^TM Protective Sealant |
| CLASSIFICATION NAME: | cavity varnish 872.3260 |
| PREDICATE DEVICES: | Seal & Protect ^TM Protective Varnish K992822 |

Seal & Protect™ Protective Varnish is a nanofilled light-curing DEVICE DESCRIPTION: dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.

Seal & Protect™ Protective Varnish is a protective sealant for exposed INTENDED USE: dentine. The Indications for Use are: 1) Reduction of abrasion of exposed cervical dentine; and 2) Treatment of hypersensitive cervical areas.

TECHNOLOGICAL CHARACTERISTICS: Seal & Protect™ Protective Sealant is identical to K992822, with the exception of the addition of a contraindication.

Therefore, we believe that Seal & Protect™ Protective Sealant is safe and effective for the unchanged indicated uses.

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## AUG 1 9 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. P. Jeffery Lehn Director, Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue York, Pennsylvania 17404

Re: K021805

Trade/Device Name: Seal & Protect™ Protective Sealant Regulation Number: 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: May 31, 2002 Received: June 3, 2002

Dear Mr. Lehn:

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 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 - Mr. Lehn

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,

Susan Tanner

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 807.87(e)

510(K) Number (if known): K021805

## SEAL & PROTECT™ PROTECTIVE SEALANT Device Name:

Seal & Protect™ Protective Sealant is a protective sealant for exposed dentine. 'The indications for use are:

- Reduction of abrasion and erosion of exposed cervical dentine .
- Treatment of hypersensitive cervical areas .

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _ OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) General

Infection Control, Dental Devices
510(k) Number: K021865

2003