(74 days)
Not Found
Not Found
No
The summary describes a fluoride varnish, a chemical preparation, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is described as a "fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity," indicating a therapeutic purpose.
No
This device is described as a "fluoride containing preparation" used for treatment and sealing, functioning as a "cavity liner." Its purpose is therapeutic and protective rather than for identifying or diagnosing a condition.
No
The device description and intended use clearly describe a physical substance (varnish) applied to teeth, not a software product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a product applied directly to the patient's teeth and root surfaces for therapeutic purposes (treating sensitivity and sealing tissue). This is a direct treatment, not a diagnostic test performed on samples taken from the body.
- Lack of Diagnostic Activity: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis.
- Anatomical Site: The anatomical sites mentioned (sensitive root surfaces, exposed dentinal tissue) are where the product is applied, not where samples are collected for analysis.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Enamel Pro® Varnish is a fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity. The varnish can be placed on sensitive root surfaces and under temporary restoratives and cements in order to seal exposed dentinal tissue. It can be used as a cavity liner.
Product codes
LBH
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its wings and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vince D'Alessandro Regulatory Manager Premier Dental Products Company 1710 Romano Drive Plymouth Meeting, Pennsylvania 19462
NOV 2 1 2006
Re: K062683
Trade/Device Name: Enamel Pro® Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: October 27, 2006 Received: October 31, 2006
Dear Mr. D'Alessandro:
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 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.
1
Page 2 - Mr. Vince D'Alessandro
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 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html
Sincerely yours,
Auythacom for
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
2
STATEMENT OF INDICATIONS FOR USE
510(k) NUMBER (IF KNOWN):
DEVICE NAME: Enamel Pro® Varnish
INDICATIONS FOR USE: Enamel Pro® Varnish is a fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity. The varnish can be placed on sensitive root surfaces and under temporary restoratives and cements in order to seal exposed dentinal tissue. It can be used as a cavity liner.
| Prescription Use ✓ | and/or | Over-the-Counter Use |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
:
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Concurrence of CDRH, Office of Device Evaluation (ODE)
Supa Omar
Gn-Off i of Anesthesiology, General Hospital, Control, Dental Devices
Number: K06682
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