SUPER SEAL TOOTH DESENSITIZER

K120109 · Phoenix Dental, Inc. · LBH · Mar 7, 2012 · Dental

Device Facts

• Record ID: K120109
• Device Name: SUPER SEAL TOOTH DESENSITIZER
• Applicant: Phoenix Dental, Inc.
• Product Code: LBH · Dental
• Decision Date: Mar 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Single application to aid in the relief from tooth sensitivity.

Device Story

Super Seal® Tooth Desensitizer is an OTC dental product applied by the user to treat dentinal sensitivity. The device contains an organic salt that reacts with calcium hydroxyapatite in the dentinal tubules. This chemical reaction forms calcium oxalate crystals, which physically occlude the tubules and inhibit fluid flow, thereby reducing sensitivity. The device is intended for single application. It provides relief from sensitivity triggered by thermal stimuli (cold/heat), dietary factors (acids/sweets), or dental whitening procedures.

Clinical Evidence

Evidence includes in-vitro studies (Kolker et al., Suzaki et al., Duran et al.) and an in-vivo study. In-vitro results demonstrated reduced dentin permeability and conical tubule occlusion. The in-vivo study evaluated 100 human cases of sensitivity, confirming effectiveness in stopping hypersensitivity. No adverse effects or safety issues were reported.

Technological Characteristics

Contains an organic salt that reacts with calcium hydroxyapatite to form calcium oxalate crystals. Mechanism involves chemical occlusion of dentinal tubules rather than surface coating. Applied via applicator.

Indications for Use

Indicated for the relief of dentinal sensitivity in patients experiencing discomfort from cold, heat, acids, sweets, or dental whitening agents.

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

• Protect Tooth Desensitizer (K050486)
• Orajel Advanced Tooth Desensitizer (K041680)

Submission Summary (Full Text)

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KI20109

MAR - 7 2012

## 510(k) Summary

| Date: | 1/12/12 |
|---------------------------|------------------------------------------------------------------------------------------------------|
| Submission: | Traditional Premarket Notification 510(k) Submission (21CFR 807.90(e)) for a new OTC medical device. |
| Company: | Phoenix Dental, Inc. |
| Contact: | Jeffrey S. Cox, President/CEO |
| Address: | 3452 West Thompson Rd. |
| City, State, Zip: | Fenton, MI 48430 |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Trade Name: | Super Seal® Tooth Desensitizer |
| Common Name: | Tooth Desensitizer |
| Panel: | Dental |
| Device Class: | Class II |
| Product Code: | LBH |
| Classification: | Varnish, Cavity |
| Substantially Equivalent: | Protect Tooth Desensitizer |
| | LBH, Varnish, Cavity |
| | K050486 |
| | Orajel Advanced Tooth Desensitizer |
| | KLE, Agent, Tooth Bonding, Resin |
| | K041680 |
| Device Description: | Super Seal ® Tooth Desensitizer is applied with an applicator by the user to aid in |

dentinal sensitivity. It contains an organic salt that reacts with the calcium hydroxyapatite in the dentinal tubules. The formation of these calcium oxalate crystals inhibits and blocks fluid flow in the tubules, thereby relieving dentinal sensitivity.

Intended Use: Single application to aid in the relief from tooth sensitivity.

Indications for Use: To aid in the relief from dentinal sensitivity caused by cold, heat, acids, sweets, or as the result from dental whitening agents.

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Technological Characteristics: Super Seal® Tooth Desensitizer as well as both predicates occlude the dentinal tubules blocking fluid flow of the dentinal complex. However, Super Seal® Tooth Desensitizer technology differs from the predicates because they place a layer that covers the tooth's surface occluding the tubules; while Super Seal® Tooth Desensitizer reacts with the calcium hydroxyapatite of the surface and peritubular dentin to form calcium oxalate crystals occluding the tubules.

Performance Data: The in-vitro Kolker et al. study evaluated the effect on permeability, hydraulic conductance and morphological tubule change. Kolker et al. showed a reduction in dentin permeability and a conical occlusion of the tubules for Super Seal®. A follow up study was performed by Suzaki et al. confirming tubule occlusion. Duran et al. study showed a decrease in permeability by tubule occlusion for HEMA based products.

Suzaki et al., in-vivo portion of their study evaluated 100 cases of human sensitivity and showed Super Seal® was effective to stop patient hypersensitivity. No adverse effects or safety issues pertaining to Super Seal® were found in any of the studies.

### Conclusion:

From the nonclinical and clinical tests that were preformed we conclude that Super Seal® Tooth Desensitizer is substantially equivalent to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

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

Mr. Jeffrey S. Cox President / CEO Phoenix Dental, Inc. 3452 West Thompson Road Fenton, Michigan 48430

MAR - 7 2012

Re: K120109

Trade/Device Name: Super Seal® Tooth Desensitizer Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: February 14, 2012 Received: February 15, 2012

Dear Mr. Cox:

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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## Page 2 - Mr. Cox

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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compriset notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

h foc

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices. Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number: K120109

Device Name: Super Seal® Tooth Desensitizer

# Indications for Use of Super Seal® Tooth Desensitizer

- To aid in the relief from dentinal sensitivity .
- This could be caused by: ●
- o Cold
- o Heat ·
- o Acids
- Sweets o
- Result from dental whitening agents O

Prescription Use __

AND/OR Over-The-Counter Use_

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D) .

> Wagi links

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(Division Sign-Otf) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120109

Revision Number: 3 Revision Date: 3/6/12