(82 days)
Intended for use as a varnish on sensitive teeth, over exposed dentin under temporary restorative and cements where post-operative sensitive and compressive and coments and cements when used in conjunction with dental restoratives and cements.
Product is also intended for use to seal dentinal tubules in cavity preparations or on sensitive root surfaces.
5% sodium fluoride in a solvent base
The provided text describes a 510(k) submission for a dental varnish (Flor-Opal Varnish) and focuses on establishing its substantial equivalence to predicate devices, rather than performing a study with acceptance criteria and device performance metrics.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, or ground truth establishment for the training set, as these details are not present in the document.
The document states:
- Intended Use: The Flor-Opal Varnish has the same intended use as predicate devices: as a varnish on sensitive teeth, over exposed dentin, under temporary restoratives and cements, and on exposed dentin on roots.
- Technological Characteristics: The technological characteristics are "virtually the same" as predicate devices, with "no significant variation."
- Materials: The materials are considered "substantially equivalent" as they are used for the same purpose and have "relatively the same properties, etc."
- Similarities to Predicate Devices:
- 5% sodium fluoride in a solvent base
- Dentinal tubule obturator for the reduction in dental hypersensitivity
- Dentist administered
- Differences from Predicate Devices: The document mentions a heading for "Differences" but the content under it is nonsensical ("1. The Partify of Children Children Children..."). It then states, "No significant differences noted with any of the predicate devices and the Flor-Opal Varnish identified, of the No significan unter thes noted with any of the picture and incredients. All have the same concentration of the active ingredient." This implies that no meaningful or relevant differences were found that would affect substantial equivalence.
In summary, the document addresses substantial equivalence by comparing the new device to existing predicate devices based on intended use, technological characteristics, and materials, rather than presenting a performance study against predefined acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo is composed of two lines of text, with the first line reading "ULTRADENT" in a bold, sans-serif font. The second line reads "PRODUCTS, INC." in a smaller, thinner font. The logo is black and white.
KOS1750
SEP 1 9 2005
SUMMARY OF SAFETY AND EFFECTIVENESS & STATEMENT OF COMPARISON
(as per 21 CFR 807.92c)
| 1) Submitted by: | Tammy LaveryUltradent Products, Inc.505 West 10200 SouthSouth Jordan, UT 98004USA |
|---|---|
| 2) Establishment Registration No: | 1718912 |
| 3) Date Prepared: | 06/21/05 |
| 4) Product Proprietary Name: | Flor-Opal Varnish |
| 5) Device Common Name: | Dental Varnish |
| 6) Device Classification Name: | Cavity Varnish (21 CFR 872.3260) |
| 7) Device Class: | Class II (76LBH) |
| 8) Substantial equivalence: | The Flor-Opal Varnish which is to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200South, South Jordan, Utah 84095, is substantiallyequivalent to the legally-marketed devices as noted onthe attached document. (Refer to section IV of this510(k) Submission for labeling and added detail for eachof the predicates identified). |
The 510(k) Substantial Equivalence Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
-
- The Flor-Opal varnish and the products listed have the same intended use, that being as varnish on sensitive teeth, over exposed dentin, under temporary restoratives and cements, and on exposed dentin on roots.
-
- The technological characteristics for this product are the virtually the same as the predicate devices listed. No significant variation has been implemented.
-
- Descriptive information per the table noted below further shows that the materials from the listed predicate devices are substantially equivalent as they are used for the same purpose and have the relatively the same properties, etc.
Page 1 of 2
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Image /page/1/Picture/0 description: The image shows the logo for Ultradent Products, Inc. The logo features a stylized "U" on the left, followed by the word "ULTRADENT" in bold, sans-serif font. Below "ULTRADENT" is the text "PRODUCTS, INC." in a smaller font size. The overall design is simple and professional, conveying a sense of reliability and innovation.
-
- As noted above, the Substantial Equivalence Decision-Making Process Chart was used.
See below for a comparison table showing similarities and differences from the predicate devices listed supporting substantial equivalence.
- As noted above, the Substantial Equivalence Decision-Making Process Chart was used.
Similarities:
| Predicate Devices | Flor-Opal Varnish |
|---|---|
| 5% sodium fluoride in a solvent base | 5% sodium fluoride in a solvent base |
| Dentinal tubule obturator for the reduction indental hypersensitivity | Dentinal tubule obturator for the reduction indental hypersensitivity |
| Dentist administered | Dentist administered |
Differences:
| Predicate Devices | Flor-Opal Varnish |
|---|---|
| 1. The Partify of Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Children Chi | " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " |
No significant differences noted with any of the predicate devices and the Flor-Opal Varnishidentified, of the No significan unter thes noted with any of the picture and incredients. All have the same concentration of the active ingredient.
Conclusion:
Per the review noted above in accordance with the guidance document, the Flor-Opal Varnish is found to be substantially equivalent to the identified predicate devices.
Peter Allen, Jr.
Peter Allred Research and Development Chemist
Tammy Lavrry
Tammy Lavery Regulatory Affairs Senior Manager
6/23/05
Date
Date
6/23/05
Date
Date
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
SEP 1 9 2005
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tammy Lavery Regulatory Affairs Senior Manager Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095
Re: K051750
Trade/Device Name: Flor-Opal Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: August 15, 2005 Received: August 26, 2005
Dear Ms. Lavery:
We have reviewed your Section 510(k) premarket notification of intent to market the devices indication We have reviewed your Section 510(x) premance from and tate the indications for the indications for referenced above and have decemined the are are as a marketed in interstate commerce
use stated in the enclosure) to legally marketed predicants, or to devices that use stated in the enclosure) to icgaily manical Device Amendments, or to devices that proof to May 28, 1970, the chacitient date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal PMAA . You may have been reclassified in accordance with the provises application (PMA). You may,
Act (Act) that do not require approval of a prematice approval application Act . The gener Act (Act) that do not require approval or a premaince of the Act . The general controls provisions of the Act include requirements for annual registration, listing of devices, good adultarstien controls provisions of the Networkships against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) most regulations affecting your device can be may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may publish found in the Code of Feach in the Federal Register.
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Page 2 – Ms. Tammy Lavery
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that ITDA 's Issualice of a substance of a subscanaties of the Act of that FDA has made a decemination that your cell by other Federal agencies. You must comply with CEP P . ( 907) any Pederal Statures and regulations administered by to: registration and listing (21 CFR Part 877); all the Act s requirements, including, but not instructive requirements as set forth in the quality labeling (21 CFR Part 801), good manakassang franks and frankle, the electronic product radiation Systems (QB) regarders (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) I his letter will anow you to begin manieting of substantial equivalence of your device to a legally prematication. The PDA Intellig of basification 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 If you desire specific davice 101 your 240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other Misoraniumig of reference to promaibilities under the Act from the Division of Small general information on your responsionner Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Ocusanti v://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carl
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
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Page_ 1_of_1
INDICATIONS FOR USE
17651450 510(k) Number (if known): Unknown
Device Name: Flor-Opal Varnish
Indications for use:
Intended for use as a varnish on sensitive teeth, over exposed dentin under temporary restorative Intended for use as a varilish of schildtive its a concern and to improve quality and functionality
and cements where post-operative sensitive and compressive and coments and cements when used in conjunction with dental restoratives and cements.
Product is also intended for use to seal dentinal tubules in cavity preparations or on sensitive root surfaces.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:_ X (Per 21 CFR 801.109)
OR
Over-The-Counter Use:_
Susan Rupp
(Optional Format 1-2-9
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Dev
510(k) Number:
§ 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.