(77 days)
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 .
Seal & Protect™ Protective Varnish is a nanofilled light-curing dental varnish designed to protect exposed dentine areas, both mechanically and by way of an antimicrobial agent.
This 510(k) summary describes a device (Seal & Protect™ Protective Sealant) that is considered substantially equivalent to a predicate device (Seal & Protect™ Protective Varnish K992822). The submission states that the new device is "identical to K992822, with the exception of the addition of a contraindication." Therefore, the focus is on demonstrating this equivalence rather than providing a separate study with acceptance criteria for the new device's performance.
Based on the provided document, there is no study conducted for Seal & Protect™ Protective Sealant to demonstrate its performance against specific acceptance criteria.
The entire premise of this 510(k) submission is that the new device is functionally the same as the predicate device, with only a minor change (an added contraindication). Therefore, the performance is assumed to be equivalent to the predicate device, for which performance would have been established previously.
Here's a breakdown based on your requested information, highlighting why much of it is not applicable or not provided in this specific 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
Explanation: This 510(k) relies on substantial equivalence to a predicate device (Seal & Protect™ Protective Varnish K992822) rather than presenting new performance data against acceptance criteria for the "new" device. The claim is that the device is "identical... with the exception of the addition of a contraindication," implying its performance is the same as the predicate.
Regarding a study proving the device meets acceptance criteria: There is no study described in this 510(k) pertaining to the performance of Seal & Protect™ Protective Sealant against specific acceptance criteria. The submission is a claim of substantial equivalence based on the device being nearly identical to a previously cleared product.
Therefore, the following points are not applicable or cannot be answered from the provided text:
2. Sample size used for the test set and the data provenance: Not applicable, as no new performance study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. 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 device is a dental sealant, not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
AUG 1 9 2002
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
st College Avenue 7105-0877
6 >1805
P. J. Lehn Telefax (717) 849-4343
| 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.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the top half of the circle. The logo is black and white.
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.
{2}------------------------------------------------
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 (301) 594-4613. 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 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 (800) 638-2041 or (301) 443-6597 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
{3}------------------------------------------------
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
§ 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.