(8 days)
Not Found
No
The summary describes a fluoride varnish for treating tooth hypersensitivity, with no mention of AI or ML technology in its intended use, device description, or performance studies.
Yes
The device is described as treating tooth hypersensitivity by occluding dentinal tubules, which aligns with the definition of a therapeutic device.
No Flor-Opal Varnish White is a treatment for tooth hypersensitivity, not a diagnostic device. Its intended use is to produce a "mechanical/chemical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity," which is a therapeutic action, not a diagnostic one.
No
The device is a physical substance (varnish) containing sodium fluoride, delivered via a syringe system. It is 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 treat tooth hypersensitivity by occluding dentinal tubules. This is a therapeutic action performed directly on the patient's tooth.
- Device Description: The description details a topical application of a fluoride varnish. This is a physical/chemical treatment applied to the tooth surface.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition. IVDs are specifically designed for diagnostic purposes.
Therefore, Flor-Opal Varnish White is a therapeutic dental device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LBH
Device 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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
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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 Varnish
White |
|-------------------------|-------------------------------------------------------------------------------------------------------------------|----------------------------|
| Intended Use | Cavity Varnish | Same |
| Type of material | Resin based | Same |
| Characteristics | Yellow-white color | White |
| Human factors | Syringe-to syringe mixing
system | Same |
| Biocompatibility/Safety | Cytotoxicity testing passed.
Literature and testing to
demonstrate product is safe
when 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, facing to the right. The eagle is composed of thick, black lines. Surrounding the eagle is a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged along the circumference of the circle.
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.
3
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
4
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)