(86 days)
Not Found
No
The summary describes a dental varnish with mechanical and antimicrobial properties, with no mention of AI or ML.
Yes.
The device is used for the "treatment of hypersensitive cervical areas," which indicates a therapeutic purpose.
No
The device is described as a protective sealant for exposed dentine used for reducing abrasion and erosion, and treating hypersensitive areas. Its function is to protect and treat, not to diagnose a condition.
No
The device description clearly states it is a "nanofilied light-curing dental varnish," which is a physical material applied to teeth, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect exposed dentine and treat hypersensitivity. This is a direct treatment applied to the patient's teeth.
- Device Description: It's a dental varnish applied to the tooth surface.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status based on in vitro testing.
IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is applied directly to the patient's teeth for therapeutic and protective purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
LBH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical dentine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
REVISED November 12, 1999
0000009