Oral-B 5% Sodium Fluoride Varnish

K153334 · Young Dental Manufacturing Co. 1, LLC · LBH · May 20, 2016 · Dental

Device Facts

• Record ID: K153334
• Device Name: Oral-B 5% Sodium Fluoride Varnish
• Applicant: Young Dental Manufacturing Co. 1, LLC
• Product Code: LBH · Dental
• Decision Date: May 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Oral-B varnish is a fluoride-containing preparation for the treatment of dental hypersensitivity, and for the reduction of post-operative sensitivity.

Device Story

Oral-B 5% Sodium Fluoride Varnish is a dental preparation used to treat dentinal hypersensitivity and reduce post-operative sensitivity. The device consists of a viscous liquid containing 5% sodium fluoride (50 mg/mL) and denatured alcohol, packaged with an applicator in a sealed tray. It is applied by a dental professional as a thin coat to tooth surfaces. The mechanism of action involves the formation of calcium fluoride, which occludes open dentin tubules. The device uses a synthetic resin base, sweeteners (sucralose, Xylitol), and flavoring agents. It is intended for prescription use in a clinical setting.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing and biocompatibility studies. Bench testing confirmed fluoride release and tubule occlusion characteristics are comparable to the predicate. Biocompatibility testing included cytotoxicity (ISO 10993-5) and irritation/sensitization (ISO 10993-10).

Technological Characteristics

Viscous liquid containing 5% sodium fluoride, synthetic resin base, denatured alcohol, sweeteners, and flavoring. Mode of action: dentin tubule occlusion via calcium fluoride formation. Applied via brush/applicator. Packaged in molded opaque acclar tray with metallized foil seal. Shelf life: 24 months.

Indications for Use

Indicated for treatment of dentinal hypersensitivity and reduction of post-operative sensitivity. Contraindicated in patients with ulcerative gingivitis and stomatitis.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• VarnishAmerica 5% Sodium Fluoride Varnish (K040098)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

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### 510(k) Summary K153334

| Sponsor: | Young Dental Manufacturing Co. 1 LLC<br>13705 Shoreline Ct. East<br>Earth City, MO 63045 |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Sarah Moore<br>Quality/Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | May 06, 2016 |
| Trade Name: | Oral-B 5% Sodium Fluoride Varnish |
| Common Name: | Cavity Varnish |
| Classification Names<br>and References: | Varnish, Cavity<br>21 CFR 872.3260, LBH |
| Classification Panel: | Dental |
| Predicate Device(s): | VarnishAmerica 5% Sodium Fluoride Varnish, Medical<br>Products Laboratories, Inc. K040098, cleared February 4,<br>2004 |
| Purpose and Description | Oral-B 5% Sodium Fluoride Varnish is a fluoride-<br>containing preparation for the treatment of dentinal<br>hypersensitivity, and for the reduction of post-operative<br>sensitivity. 1mL of varnish contains 50 mg of sodium<br>fluoride, equivalent to 22.6 mg fluoride ion. Varnish is<br>sweetened with sucralose and Xylitol, and flavored.<br>Varnish and applicator are packaged together in a molded<br>opaque acclar tray, and sealed with a metallized foil. |
| Intended Use: | Oral-B varnish is a fluoride-containing preparation for the<br>treatment of dental hypersensitivity, and for the reduction<br>of post-operative sensitivity. |
| Technological Characteristics | The fundamental principle and primary mode of action of<br>both the Oral-B varnish and the predicate in reducing |

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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 Fluoride<br>Varnish | VarnishAmerica 5% Sodium<br>Fluoride Varnish-<br>Predicate Device |
|----------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| | K153334 | K040098 |
| Indications for use | Treatment of dental<br>hypersensitivity and Reduction<br>of post-operative sensitivity | Treatment of dental hypersensitivity<br>and Reduction of post-operative<br>sensitivity |
| Contraindications | Ulcerative gingivitis and<br>stomatitis | Ulcerative gingivitis and stomatitis |
| Mode of action | Dentin Tubule Occlusion | Dentin Tubule Occlusion |
| Method of application | Application of a thin coat of<br>varnish on tooth surfaces | Application of a thin coat of varnish<br>on tooth surfaces |
| Percentage of sodium<br>fluoride | 5% | 5% |
| Packaging | Varnish and applicator brush<br>placed in a molded opaque<br>acclar tray and closed with a<br>foil seal | Varnish and applicator brush placed<br>in a molded opaque acclar tray and<br>closed with a foil seal |
| Unit package | 0.4mL | 0.4mL |
| Base Material | Synthetic Rosin | Natural Rosin |

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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.