Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Device Description

Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post-operative sensitivity. 1mL of varnish contains 50 mg of sodium fluoride, equivalent to 22.6 mg fluoride ion. Varnish is sweetened with sucralose and Xylitol, and flavored. Varnish and applicator are packaged together in a molded opaque acclar tray, and sealed with a metallized foil.

AI/ML Overview

Here's an analysis based on the provided document, addressing your questions about acceptance criteria and the supporting study:

The provided document (K153334) is a 510(k) premarket notification for the Oral-B 5% Sodium Fluoride Varnish. It's important to understand that this document describes a submission seeking substantial equivalence to a predicate device, not necessarily a study proving a device meets specific pre-defined acceptance criteria for efficacy or safety in a new, standalone clinical trial. The focus here is on demonstrating that the new device is as safe and effective as an already legally marketed predicate device.

Therefore, many of your questions, particularly those related to a clinical study with detailed performance metrics, ground truth establishment, expert adjudication, or MRMC studies, are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding performance data and the comparison to the predicate device.

1. A table of acceptance criteria and the reported device performance

Since this is a 510(k) submission seeking substantial equivalence to a predicate, the "acceptance criteria" are generally that the new device performs as expected and is comparable to the predicate device in relevant quantifiable aspects, and is safe and effective for its intended use. Specific quantitative performance "acceptance criteria" and direct numerical "reported device performance" are not explicitly listed in the format you might see for a de novo or PMA submission. Instead, the document focuses on demonstrating comparability.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (Oral-B 5% Sodium Fluoride Varnish)
Fluoride Release: Comparable to predicate.	Confirmed to be as expected and comparable to the predicate (VarnishAmerica 5% Sodium Fluoride Varnish).
Dentin Tubule Occlusion: Comparable to predicate.	Confirmed to be as expected and comparable to the predicate.
Biocompatibility (Cytotoxicity): Equivalent to predicate.	Tested per ISO 10993-5 (cytotoxicity) with equivalent results to the predicate. Also tested for irritation and sensitization per ISO 10993-10, providing evidence of biocompatibility.
Shelf Life: Meets defined protocols and specifications.	Declared to be 24 months in accordance with defined protocols and acceptance specifications.

2. Sample size used for the test set and the data provenance

The document mentions "Performance - Comparative bench testing with the predicate was carried out by independent laboratories." However, it does not specify the sample size for these bench tests.

Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It only mentions "independent laboratories" performed the testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. For bench testing related to fluoride release and tubule occlusion, the "ground truth" would be established by the measurement methods themselves, adhering to scientific standards, rather than expert interpretation of results in the way ground truth is established for diagnostic devices (e.g., by radiologists).

4. Adjudication method for the test set

This information is not applicable/not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for diagnostic outputs where multiple experts interpret data. The tests described here are bench tests for physical/chemical properties.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done and is not mentioned. The document states, "Clinical data were not needed for these devices to show substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical product (fluoride varnish), not a software algorithm.

7. The type of ground truth used

For the nonclinical performance data mentioned:

Fluoride Release and Dentin Tubule Occlusion: The "ground truth" is derived from objective laboratory measurements based on established scientific protocols and methods. This is not "expert consensus," "pathology," or "outcomes data" in the usual sense.
Biocompatibility: The "ground truth" is established by adherence to international standards (ISO 10993-5 and ISO 10993-10) and the specific biological responses observed in the tests.

8. The sample size for the training set

This is not applicable/not provided. The device is a physical product, and the testing described does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this type of device and submission.

Summary of the Study:

The "study" described in the 510(k) summary is primarily a non-clinical bench testing comparison of the Oral-B 5% Sodium Fluoride Varnish against a legally marketed predicate device (VarnishAmerica 5% Sodium Fluoride Varnish).

Objective: To demonstrate substantial equivalence of the new device to the predicate device.
Methods: Comparative bench testing was performed by independent laboratories for:
- Fluoride release
- Dentin tubule occlusion
- Biocompatibility (cytotoxicity, irritation, sensitization) per ISO 10993 standards.
- Shelf-life determination.
Findings: The Oral-B varnish's fluoride release and tubule occlusion characteristics were found to be "as expected and comparable to the predicate." Biocompatibility testing yielded "equivalent results" for cytotoxicity and provided "evidence of biocompatibility" for irritation and sensitization. A 24-month shelf life was established.
Conclusion: The non-clinical performance data, along with composition and indications for use, established that Oral-B varnish is substantially equivalent to the predicate device. Clinical data were deemed unnecessary for this demonstration.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2016

Young Dental Manufacturing Co 1, LLC. Ms. Sarah Moore Director of Quality and Regulatory Affairs 13705 Shoreline Ct. East Earth City, Missouri 63045

Re: K153334

Trade/Device Name: Oral-B 5% Sodium Fluoride Varnish Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: April 14, 2016 Received: April 18, 2016

Dear Ms. Moore:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

{1}------------------------------------------------

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): medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K153334

Device Name Oral-B 5% Sodium Fluoride Varnish

Indications for Use (Describe)

Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "YOUNG" in large, bold, blue letters. The letters are spaced closely together, creating a solid block of text. A small trademark symbol is located to the right of the letter "G".

510(k) Summary K153334

Sponsor:	Young Dental Manufacturing Co. 1 LLC13705 Shoreline Ct. EastEarth City, MO 63045
Contact Person:	Sarah MooreQuality/Regulatory AffairsTelephone: 314-372-8040Fax: 314-344-0021
Date:	May 06, 2016
Trade Name:	Oral-B 5% Sodium Fluoride Varnish
Common Name:	Cavity Varnish
Classification Namesand References:	Varnish, Cavity21 CFR 872.3260, LBH
Classification Panel:	Dental
Predicate Device(s):	VarnishAmerica 5% Sodium Fluoride Varnish, MedicalProducts Laboratories, Inc. K040098, cleared February 4,2004
Purpose and Description	Oral-B 5% Sodium Fluoride Varnish is a fluoride-containing preparation for the treatment of dentinalhypersensitivity, and for the reduction of post-operativesensitivity. 1mL of varnish contains 50 mg of sodiumfluoride, equivalent to 22.6 mg fluoride ion. Varnish issweetened with sucralose and Xylitol, and flavored.Varnish and applicator are packaged together in a moldedopaque acclar tray, and sealed with a metallized foil.
Intended Use:	Oral-B varnish is a fluoride-containing preparation for thetreatment of dental hypersensitivity, and for the reductionof post-operative sensitivity.
Technological Characteristics	The fundamental principle and primary mode of action ofboth the Oral-B varnish and the predicate in reducing

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the word "YOUNG" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. There is a trademark symbol to the right of the word.

dental hypersensitivity is the occlusion of open dentin tubules. Oral-b and the predicate exist as a viscous liquid that is able to be applied to the teeth using a brush or similar applicator. Both the Oral-B and the predicate employ 5% sodium fluoride as the source of fluoride ions for the formation of calcium fluoride which occludes the dentin tubules. Both use denatured alcohol as a significant component, providing fluidity for application and to promote quick drying on the tooth surface.

The technological difference between the Oral-B varnish and the predicate is the formulation of components. The Oral-B varnish uses a synthetic resin as the base material instead of the natural rosin used in the predicate. Oral-B also includes an additional base material, sweeteners, and flavoring agents.

Comparison to Predicate Device:

The table below summarizes the similarities and differences between Oral-B 5% Sodium Fluoride Varnish and the predicate device:

	Oral-B 5% Sodium FluorideVarnish	VarnishAmerica 5% SodiumFluoride Varnish-Predicate Device
	K153334	K040098
Indications for use	Treatment of dentalhypersensitivity and Reductionof post-operative sensitivity	Treatment of dental hypersensitivityand Reduction of post-operativesensitivity
Contraindications	Ulcerative gingivitis andstomatitis	Ulcerative gingivitis and stomatitis
Mode of action	Dentin Tubule Occlusion	Dentin Tubule Occlusion
Method of application	Application of a thin coat ofvarnish on tooth surfaces	Application of a thin coat of varnishon tooth surfaces
Percentage of sodiumfluoride	5%	5%
Packaging	Varnish and applicator brushplaced in a molded opaqueacclar tray and closed with afoil seal	Varnish and applicator brush placedin a molded opaque acclar tray andclosed with a foil seal
Unit package	0.4mL	0.4mL
Base Material	Synthetic Rosin	Natural Rosin

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "YOUNG" in large, bold, blue letters. The letters are sans-serif and appear to be a custom font. A small trademark symbol is located to the right of the letter "G".

Fluoride Release and Dentin Tubule Occlusion Performance Data (Nonclinical): Performance - Comparative bench testing with the predicate was carried out by independent laboratories. Bench testing confirmed that the fluoride release and tubule occlusion characteristics of Oral-B varnish are as expected and comparable to the predicate. . Shelf Life – The shelf life of this device is declared to be 24 months in accordance with defined protocols and acceptance specifications and have provided the rationale for establishment of this shelf life. . Biocompatibility - Oral-B varnish and the predicate were tested for cytotoxicity per ISO 10993-5 with equivalent results. Oral-B varnish was also tested for irritation and sensitization per ISO 10993-10. Test results provide evidence of biocompatibility. Performance Data (Clinical): Clinical data were not needed for these devices to show substantial equivalence. Conclusions: The information presented in this submission including composition and indications for use, together with biocompatibility and non-clinical performance testing establish that Oral-B varnish is substantially equivalent to the predicate.

Regulation Number and Section

§ 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.