SENZZZZZ AWAY

K120176 · Centrix, Inc. · LBH · Jul 25, 2012 · Dental

Device Facts

• Record ID: K120176
• Device Name: SENZZZZZ AWAY
• Applicant: Centrix, Inc.
• Product Code: LBH · Dental
• Decision Date: Jul 25, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Senzzzzz A way™ is to be used to relieve dental hypersensitivity. or D/Sense® Crystal™ is to be used to relieve dental hypersensitivity.

Device Story

Senzzzzz Away is an oxalate-based tooth desensitizing agent; formulated as a one-part opaque gel for single-use. Intended for over-the-counter use by consumers to treat dentinal hypersensitivity. Mechanism involves tubule occlusion and reduction of nerve excitability. Packaged in a single-use tray with an applicator. Applied topically to teeth by the patient. Benefits include reduced pain response to thermal and chemical stimuli.

Clinical Evidence

Evidence includes bench testing (scanning electron microscopy of extracted teeth confirming tubule occlusion) and a six-month clinical effectiveness study demonstrating reduction in sensitivity. A consumer ease-of-use study was conducted to validate suitability for over-the-counter purchase.

Technological Characteristics

Oxalate-based desensitizing agent; one-part opaque gel. Single-use tray and applicator form factor. Mechanism: tubule occlusion and nerve excitability reduction. Non-electronic, chemical-based dental varnish.

Indications for Use

Indicated for the relief of dental hypersensitivity in patients experiencing sensitivity to hot, cold, or sweet stimuli.

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

• D/Sense 1-Step (K021146)
• Super Seal Tooth Desensitizer (K983477)
• Super Seal Tooth Desensitizer (K120109)
• Protect Tooth Desensitizer (K050486)
• Oralief Therapy for Sensitive Teeth (K040858)
• Remesense (K082594)
• BisBlock (K033521)
• UltraEZ Desensitizing Gel (K061438)

Submission Summary (Full Text)

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510(k) Summary

K120176

Senzzzzzz Away

## 510(k) Summary

Centrix, Inc.

JUL 2 5 2012

### Senzzzzzz Away

July 12, 2012

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Centrix, Inc. 770 River Road Shelton, CT 06484 Telephone: [phone] Fax: [phone]

Official Contact:

Greg Moreau RA/QA Director

Representative/Consultant:

Linda K. Schulz Allison C. Komiyama Floyd G. Larson PaxMed International, LLC l 1234 Ei Camino Real, Suite 200 San Diego, CA 92130 Telephone: [phone] Fax: [phone] Email: [e-mail] [e-mail] [e-mail]

#### DEVICE NAME AND CLASSIFICATION

| Trade/Proprietary Name: | Senzzzzz Away |
|-----------------------------|--------------------------|
| Classification Name: | Cavity Varnish |
| Classification Regulations: | 21 CFR 872.3260, Class I |
| Product Code: | LBH |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch: | Dental Devices Branch |

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#### INTENDED USE

Senzzzzz A way™ is to be used to relieve dental hypersensitivity. or D/Sense® Crystal™ is to be used to relieve dental hypersensitivity.

#### DEVICE DESCRIPTION

Senzzzzz Away is an oxalate tooth desensitizing agent intended for over-the-counter-use. The combination of tubule occlusion and reduction in nerve excitability shown with oxalate formulations is responsible for the reduction in dentinal hypersensitivity to cold, hot and sweets. Senzzzzz Away is a one-part, opaque gel for single use.

#### EQUIVALENCE TO MARKETED DEVICE

Centrix, Inc., D/Sense® 1-Step cleared under K021146,

Phoenix Dental, Inc., Super Seal® Tooth Desensitizer cleared under K983477 and K 120109

Sunstar Butler, Protect™ Tooth Desensitizer cleared under K050486

NovaMin Technology, Inc., Oralief™ Therapy for Sensitive Teeth cleared under K040858

Remedent NV, Remesense cleared under K082594

Bisco, Inc., BisBlock cleared under K033521

Ultradent Products, Inc., UltraEZ Desensitizing Gel cleared under K061438

| Device Name | Classification Name | Mode of Action | Application | Material |
|----------------------------------------------------------|---------------------------------------------------|---------------------|---------------------------|---------------------------------------|
| Senzzzzz Away<br>(or D/Sense Crystal)<br>D/Sense® 1-Step | Cavity varnish, Calcium<br>hydroxide cavity liner | Tubule<br>Occlusion | Paint-on gel | Oxalate |
| Super Seal® Tooth<br>Desensitizer | Cavity varnish | Tubule<br>Occlusion | Applicator | Oxalate |
| Protect™ Tooth<br>Desensitizer | Cavity varnish | Tubule<br>Occlusion | Paint on liquid | Oxalate |
| Oralief™ Therapy<br>for Sensitive Teeth | Cavity varnish | Tubule<br>Occlusion | Brush on paste | Calcium sodium<br>phosphosilicate |
| Remesense | Cavity varnish | Tubule<br>Occlusion | Tray and<br>foam strips | Oxalate |
| BisBlock | Calcium<br>hydroxide cavity liner | Tubule<br>Occlusion | Etch+apply<br>liquid+seal | Oxalate |
| UltraEZ<br>Desensitizing Gel | Cavity varnish | Tubule<br>Occlusion | Tray and gel | Potassium nitrate<br>Fluoride ion gel |

#### Comparison of Technological Characteristics

Senzzzzz Away tooth desensitizer is the over-the-counter version of D/Sense® Crystal™ (previously D/Sense 1-Step). Senzzzzz Away is packaged in a single use tray with applicator for consumer use. All of the predicates use tubule occlusion as a mechanism for controlling dental hypersensitivity. Oxalate formulations also have an effect on nerve excitability to reduce pain sensitivity.

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### 510(k) Summary

Side-by-side biocompatibility testing was performed on the subject and predicate devices. Scanning electron microscopy images of extracted teeth before and after device application demonstrated that the device seals and occludes dentinal tubules.

A consumer ease-of-use study conducted for Senzzzzz Away to ensure that patient use of the product was appropriate for over-the-counter purchase. A six month effectiveness study was performed to demonstrate the reduction in sensitivity. The combination of these studies shows Senzzzzz Away is safe and effective for over-the-counter use.

Overall, Senzzzzz Away has the following similarities to the predicate devices:

- . has the same intended use,
- . uses a similar operating principle,
- . incorporates the same basic design, .
- incorporates the same or similar materials, and ●
- . has similar packaging.

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

# AUG -3 2012

Centrix. Incorporated C/O Ms. Linda K. Schulz PaxMed International. LLC 11234 Camino Real, Suite 200 San Diego, California 92130

Re: K120176

Trade/Device Name: Senzzzzz Away™ (OTC), D/Sense® Crystal™ (Rx) Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: June 29, 2012 Received: July 2, 2012

Dear Ms. Schulz:

This letter corrects our substantially equivalent letter of July 25, 2012.

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 (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 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- Ms. Schulz

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 premarket 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

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## Indications for Use

K120176 510(k) Number:

Senzzzzz Away™ (OTC), D/Sense® Crystal™ (Rx) Device Name:

Indications for Use:

To relieve dental hypersensitivity.

Over-The-Counter Use X Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) wision of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K120176