(77 days)
Not Found
No
The 510(k) summary describes a dental varnish and does not mention any AI or ML components, image processing, or performance studies typically associated with AI/ML devices.
No.
The intended use describes the product as a varnish used to seal dentinal tubules and improve the quality of restorations, which suggests it is a dental material, not a therapeutic device designed to treat a disease or condition. The listed predicate devices are also varnishes.
No
This device is intended for use as a varnish to treat sensitivity and improve restorations, not to diagnose a condition.
No
The intended use describes a varnish applied to teeth, which is a physical substance, not software. The predicate devices are also varnishes.
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 to teeth and dentin to reduce sensitivity and improve restorations. This is a direct application to the patient's body for therapeutic or protective purposes.
- Anatomical Site: The anatomical sites mentioned (teeth, dentin, roots, dentinal tubules) are all within the patient's body.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples taken from the body (like blood, urine, tissue).
- Providing information about a physiological state, disease, or condition based on the analysis of these samples.
- Any laboratory testing or diagnostic procedures.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device's function is entirely external to this definition.
N/A
Intended Use / Indications for Use
Int inded for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive roc t surfaces.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sensitive teeth, exposed dentin, dentinal tubules
Indicated Patient Age Range
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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)
Not Found
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
MAY - 2 2003
Image /page/0/Picture/2 description: The image shows the logo for Pascal Company, Inc. The logo features a stylized, abstract shape on the left, followed by the word "Pascal" in a bold, sans-serif font. Underneath "Pascal" is the text "Company, Inc." in a smaller font size.
WATS 800/426-805
VII. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS (AS F:EQUIRED BY SECTION 807.92C)
| Submitted by:
- | | | | 1) |
|--------------------|--|--|--|----|
|--------------------|--|--|--|----|
Vincent M. Tentarelli Pascal Company, Inc. 2929 NE Northup Way Bellevue, WA 98004 USA Establishment Registration No.: 3011632 2) Date Prepared: March 1, 2003 3) 4) Device Trade Name: Fluorilaq Fluoride Varnish Device Common Name Dental Varnish 5) Cavity Varnish Device Classification Name: 6) Device Class: Class II 7)
-
- Substantial equivalence: Fluorilaq is substantially equivalent to the originally classified device described in CFR 872.3260 "Varnish, cavity." It is also substantially equivalent and nearly identical to (for example ) the following products that are currently on the market, having been cleared by 510(k)s:
| 510(k) Number | Name of Device | Company |
|---|---|---|
| K982915 | Sci-Pharm DVF Varnish | Scientific Pharmaceuticals, Inc. |
| K945794 | Duraphat | Inpharma |
| K961893 | Duraflor | Pharmascience, Inc. |
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- The document, "Guidance on the CDRH Premarket Notification Review Program, June 30, 1986 (K86-3)" was used to determine substantial equivalence:
- Fluorilag has the same intended use, as a varnish on sensitive teeth over a) exposed dentin under temporary restoratives and cements and exposed dentin on roots, as many cleared by the 510(k) process as shown above.
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- b) The technological characteristics for this product are the same as those for the predicate devices and other resinous products currently on the market except for minor variations in the same or similar components.
- Descriptive information provided shows that the materials from which Pascal c) Co., Inc.'s Fluorilaq is made are substantially equivalent to (nearly identical with some) those of similar products, used for identical purposes, currently on the market.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and appear to be connected.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2003
Mr. Vincent M. Tentarelli Ouality Assurance Manager Pascal Company, Incorporated 2929 NE Northup Way Bellevue, Washington 98004
Re: K030488
Trade/Device Name: FLUORILAO Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity varnish Regulatory Class: II Product Code: LBH Dated: February 13, 2003 Received: February 14, 2003
Dear Mr. Tentarelli:
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.
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Page 2 - Mr. Tentarelli
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 (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), please contact the Office of Compliance at (301) 594-4613. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Susan Runner
Susan Runner. DDS. MA Interim 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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V. STATIEMENT OF INDICATIONS FOR USE
INDICATIONS
Int inded for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive roc t surfaces.
Kein Mulry fa MSM
Division Sign-General Hospital, Division of Anesthesiology, Infection Control, Dental D
510(k) Number: K 030488