(122 days)
VOCO Profluorid Varnish is intended for use as
- Treatment of hypersensitive teeth,
- Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces
- Cavity liner under amalgam restorations
VOCO Profluorid Varnish is a fluoride containing dental varnish for application to enamel surfaces as well as dentin for the treatment of hypersensitive teeth and for use as a cavity liner under amaigam restorations. VOCO Profluorid Varnish will for use as cavily a is tolerant to moisture and saliva.
This document is a 510(k) summary for the VOCO Profluorid Varnish, a dental product. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way described in the request.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly present in the provided text. The document's purpose is to clear the device for market based on its similarity to existing, legally marketed devices and the established safety of its components.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the document in the format of a typical performance study with specific acceptance criteria and reported results. The document relies on the "prior use of all of the components... in legally marketed devices" and "performance data and results provided" from those predicate devices to support its safety and effectiveness.
The document states:
- "The prior use of all of the components of VOCO Profluorid Varnish in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary."
- "We believe that the prior use of the components of VOCO Profluorid Varnish in legally marketed devices and the performance data and results provided support the safety and effectiveness of VOCO Profluorid Varnish for the intended use."
This implies the acceptance criterion is essentially "demonstrates substantial equivalence to predicate devices which have established safety and effectiveness through their long-term market presence and prior data." The performance is implicitly accepted as being equivalent to these predicate devices.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided for this submission. This submission does not detail a new clinical test set for performance. It relies on the established safety and performance of its components and predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided for this submission. There is no independent establishment of ground truth for a new test set described.
4. Adjudication method for the test set
Not applicable/Not provided for this submission. Since no new test set with human assessment is described, there's no adjudication method.
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 varnish, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical dental product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The 'ground truth' for the safety and effectiveness of the components and the device's indications for use is based on the established regulatory clearance and market history of the predicate devices (Duraphat Fluoride Varnish K945794, K031932, and Duraflor Cavity Varnish K961893) and the FDA's clearance of ethyl cellulose as a food additive.
8. The sample size for the training set
Not applicable/Not provided for this submission. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided for this submission. See point 8.
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Image /page/0/Picture/0 description: The image shows four black shapes arranged horizontally. The first shape is a triangle with a rectangle cut out of the top. The second shape is a circle with a smaller circle cut out of the center. The third shape is a circle with a wedge cut out of it. The fourth shape is a circle with a smaller circle cut out of the center and a vertical line through it.
JUL 2 4 2008
Anton-Flettner-Straße 27472 Cuxhaven · Germany +49 4721 719-1 49 4721 719-140 . Info@yoco do
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------VOCO GmbH · Postfach 7 67 · 27457 Cuxhaven · Germany
510(k) SUMMARY
Contact: M. Th. Plaumann
Date prepared: March 20, 2008
Trade or proprietary name: VOCO Profiluorid Varnish
Classification name: Varnish, Cavity (872 3260)
| Predicate device: | DuraphatFluoride Varnish | K945794K031932 |
|---|---|---|
| ------------------- | ------------------------------ | -------------------- |
Device description:
VOCO Profluorid Varnish is a fluoride containing dental varnish for application to enamel surfaces as well as dentin for the treatment of hypersensitive teeth and for use as a cavity liner under amaigam restorations. VOCO Profluorid Varnish will for use as cavily a is tolerant to moisture and saliva.
Intended use: VOCO Profluorid Varnish is intended for use as a desensitizing agent for the treatment of hypersensitive teeth, for sealing the dentinal tubules for cavity preparations or on sensitive root surfaces or to line cavity preparations under amalgam restorations.
Technological characteristics: All of the components of VOCO Profluorid Varnish are found in the legally marketed devices K945794 (Duraphat), K031932 (Fluoride Varnish) and K961893 (Duraflor Cavity Varnish) with the exception of ethyl cellulose which has been cleared by FDA as a food additive permitted for direct addition to food for human use (?) CFR 172.868).
The prior use of all of the components of VOCO Profluorid Varnish in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as wel as additional biocompatibility studies with the final formulation are not necessary We believe that the prior use of the components of VOCO Profluorid Varnish in legally marketed devices and the performance data and results provided support the safety an effectiveness of VOCO Profluorid Varnish for the intended use.
VOCO GmbH, March 20, 2008
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, with its head facing left and its wings forming three distinct, curved lines. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. M. Th. Plaumann Managing Board VOCO GmbH Anton-Flettner-Strasse 1-3 Cuxhaven GERMANY D-27472
Re: K080814
Trade/Device Name: VOCO Profluorid Varnish Regulation Number: 21CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: July 15, 2008 Received: July 18, 2008
Dear Mr. Plaumann:
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.
JUL 2 4 2008
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. Plaumann
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
Samuel Fox 11
Chiu Lin, Ph.D. 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
| 510(k) Number: | K080814 |
|---|---|
| Device Name: | VOCO Profluorid Varnish |
| Indications for Use: |
VOCO Profluorid Varnish is intended for use as
- Treatment of hypersensitive teeth,
- Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces
- Cavity liner under amalgam restorations
| Prescription Use X | OR | Over-The-Counter Use _____ |
|---|---|---|
| ---------------------- | ---- | ---------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: R080804
§ 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.