(8 days)
Flor-Opal Varnish White is a 5% sodium fluoride in a varnish carrier which produces a mechanical/chemical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Flor-Opal Varnish White is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier, delivered in a .5ml unit-dose syringe-to-syringe mixing system. A pleasantly flavored 5% neutral sodium fluoride in a varnish carrier for relief in dental hypersensitivity. 1ml of varnish contains 50mg of sodium fluoride in an alcohol and natural resin suspension. The varnish adheres well to a wet or dry tooth surface and is white in color when dry. It tolerates saliva, and food while occluding the dentinal tubules.
The provided document does not contain the acceptance criteria or results of a study as one would expect for a medical device's performance evaluation against specific metrics. Instead, it is a 510(k) summary for a Special 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study.
Here's why the requested information cannot be extracted from this document and what the document does communicate:
- Nature of the Submission: This is a Special 510(k) submission for Flor-Opal Varnish White. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modification does not affect the device's fundamental scientific technology or its intended use. The primary goal is to show the new device is substantially equivalent to the predicate device, not to prove performance against specific acceptance criteria in a clinical trial.
- Demonstration of Equivalence: The document achieves its objective by comparing the new device (Flor-Opal Varnish White) to its predicate (Flor-Opal Varnish K051750). The comparison focuses on:
- Intended Use: Same
- Type of Material: Same (Resin based)
- Human Factors: Same (Syringe-to-syringe mixing system)
- Biocompatibility/Safety: Same (Cytotoxicity testing passed for predicate, implied for new device)
- Characteristic Difference: The predicate is "Yellow-white color" while the new device is "White." This is the primary characteristic change highlighted.
Therefore, since this is a substantial equivalence (510(k)) submission and not a de novo clinical performance study, the document does not include the detailed performance evaluation against acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies that would be present in a traditional clinical study report.
However, I can extract the closest information available related to "acceptance criteria" and "study" as implied by a 510(k) context:
1. A table of acceptance criteria and the reported device performance
In the context of this 510(k), "acceptance criteria" relates to the properties that must be similar or equivalent to the predicate device. "Reported device performance" is largely expressed through the claim of "Same" or "passed."
| Property | Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (Flor-Opal Varnish White) |
|---|---|---|
| Intended Use | Must be the same as the predicate | Same |
| Type of material | Must be the same as the predicate (resin based) | Same |
| Human factors | Must be the same as the predicate (syringe-to-syringe mixing system) | Same |
| Biocompatibility/Safety | Must pass cytotoxicity testing and be safe/effective as per predicate | Same (as demonstrated by predicate testing) |
| Technological Characteristics | Must align with predicate's functional description (5% sodium fluoride, varnish carrier, etc.) | Aligns (flavored 5% neutral sodium fluoride in a varnish carrier) |
| Physical Appearance | (Characteristic difference noted) | White (vs. Yellow-white for predicate) |
| Internal Test Specifications (Lot Release) | Each lot must pass internal test specifications prior to release | Each lot of product must pass internal test specifications prior to release |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify a sample size for a "test set" related to clinical performance. The comparison is based on the characteristics of the device itself and its equivalence to the predicate.
- The biocompatibility testing mentioned for the predicate (and by extension, the new device) is acknowledged, but the details of those tests (sample size, provenance) are not provided in this summary. It states "Cytotoxicity testing passed. Literature and testing to demonstrate product is safe when used as directed" for the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not applicable to this type of 510(k) submission. There was no clinical "test set" requiring expert ground truth in the traditional sense. The judgment of "substantial equivalence" is made by the FDA based on the provided technical and comparative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as there was no clinical "test set" and no adjudication process described for clinical outcomes.
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
- This information is not applicable. This device is a dental varnish, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This device is a dental varnish, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the demonstration of substantial equivalence, the "ground truth" is primarily technical specifications and existing biocompatibility data of the predicate device. The change (color) is an observable physical characteristic. The ongoing safety and effectiveness are established by the predicate and the shared fundamental technology.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not an algorithm being developed.
9. How the ground truth for the training set was established
- This information is not applicable. There is no "training set."
In summary, the document details a Special 510(k) submission for a modified dental varnish, focusing on demonstrating substantial equivalence to a predicate device rather than presenting results from a clinical performance study with defined acceptance criteria and ground truth derived from expert review.
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Special 510(k) Flor-Opal Varnish White
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SPECIAL 510(K) SUMMARY
Flor-Opal Varnish White
This summary of the Traditional 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for Flor-Opal Varnish White
Applicant's Name and Address
Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095
Contact Person: Title: Telephone: FAX: Date Summary Prepared:
Diane Rogers Regulatory Affairs Product Specialist 800-552-5512 x4491, 801-553-4491 801-553-4609 January 23, 2008
FEB - 8 . ...
Name of the Device
Trade Name: Common Name: Device Classification: Classification Product Code: Flor-Opal Varnish White Cavity Varnish ll LBH
Legally Marketed Predicate Devices to Which Equivalence is Claimed
The predicate device is Flor-Opal Varnish (K051750) This device is manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, Utah 84095.
Product Description: Flor-Opal Varnish White is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier, delivered in a .5ml unit-dose syringe-to-syringe mixing system.
Indications for Use: Flor-Opal Varnish White is a 5% sodium fluoride in a varnish carrier which produces a mechanical/chemical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
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Table 1: Product Comparison
| Property | Predicate:Flor-Opal Varnish (K051750) | Flor-Opal VarnishWhite |
|---|---|---|
| Intended Use | Cavity Varnish | Same |
| Type of material | Resin based | Same |
| Characteristics | Yellow-white color | White |
| Human factors | Syringe-to syringe mixingsystem | Same |
| Biocompatibility/Safety | Cytotoxicity testing passed.Literature and testing todemonstrate product is safewhen used as directed | Same |
Technological Characteristics
A pleasantly flavored 5% neutral sodium fluoride in a varnish carrier for relief in dental hypersensitivity. 1ml of varnish contains 50mg of sodium fluoride in an alcohol and natural resin suspension. The varnish adheres well to a wet or dry tooth surface and is white in color when dry. It tolerates saliva, and food while occluding the dentinal tubules.
Brief Description of Testing Performed
Each lot of product must pass internal test specifications prior to release. The results of biocompatibility testing demonstrate that Flor-Opal Varnish WHITE is safe and effective when used according to the Instructions for Use.
Conclusion and Substantial Equivalence
In conclusion, Flor-Opal Varnish WHITE, to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, UT 84095, is substantially equivalent to the Flor-Opal Varnish (K051750), also manufactured by Ultradent Products, Inc. The two products are composed of nearly the same materials, have the same intended use and technological characteristics, and both are safe and effective when used for the indications described.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 8 2008
Ms. Diane Rogers Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K080249
Trade/Device Name: Flor-Opal Varnish White Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: January 31, 2008 Received: February 4, 2008
Dear Ms. Rogers:
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- Ms. Rogers
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 (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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Quc
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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Statement of Indications for Use
60861 4 9 510(k) Number (if known):
Flor-Opal Varnish White Device Name:
Indications for Use: Flor-Opal Varnish White is 5% sodium fluoride in a varnish carrier which produces a mechanical/chemical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
WDA (Division Sign-Off) Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K080247
Page 1 of _1
(Posted November 13, 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.