DURASHIELD PLUS

K082198 · Dentsply Intl., Inc. · LBH · Oct 29, 2008 · Dental

Device Facts

• Record ID: K082198
• Device Name: DURASHIELD PLUS
• Applicant: Dentsply Intl., Inc.
• Product Code: LBH · Dental
• Decision Date: Oct 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.

Device Story

DURASHIELD® PLUS is a flavored, topically applied cavity varnish; contains sodium fluoride and NovaMin (bio-available calcium phosphosilicate). Applied by dental professionals to teeth; varnish forms a water- and saliva-insoluble layer. Upon exposure to moisture, NovaMin releases calcium and phosphorous ions to facilitate natural tooth remineralization. Primary clinical benefit is the relief of dental hypersensitivity caused by exposed dentin and cementum.

Clinical Evidence

No clinical data. Biocompatibility of components evaluated based on prior use and oral toxicity testing.

Technological Characteristics

Viscous liquid cavity varnish; contains sodium fluoride and NovaMin (calcium phosphosilicate). Insoluble in water and saliva. Functions as a topical desensitizing agent.

Indications for Use

Indicated for relief of dental hypersensitivity in patients with exposed dentin and cementum.

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

• Sci-Pharm DFV Varnish (K982915)
• Sultan Tooth Root Desensitizer (K072342)

Submission Summary (Full Text)

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K082198

. of 2

OCT 2 9 2000

### 510(k) SUMMARY for DURASHIELD® PLUS

DENTSPLY International World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 [phone]
Fox [phone] www.dentsply.com

1. Submitter Information: DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street

Fax Number:

York, PA 17405 Contact Person: Helen Lewis Telephone Number: 717-849-4229

Date Prepared: July 31, 2008

- 2. Device Name:
- Proprietary Name: DURASHIELD® PLUS . Classification Name: Cavity Varnish . CFR Number: 872.3260 � Device Class: II e Product Code: гвн .

717-849-4343

- 3. Predicate Device:

| Company | Device | 510(k) Number | Date Cleared |
|-------------------------------------|-----------------------------------|---------------|--------------|
| Scientific Pharmaceuticals,<br>Inc. | Sci-Pharm DFV Varnish | K982915 | 02/12/1999 |
| NovaMin Technology, Inc. | Sultan Tooth Root<br>Desensitizer | K072342 | 10/03/2007 |

- 4. Description of Device:
DURASHIELD® PLUS is a topically applied, flavored cavity varnish containing sodium fluoride and NovaMin. The varnish is a viscous liquid and is insoluble in water and saliva. NovaMin is a bio-available calcium phosphosilicate that releases calcium and phosphorous when exposed to moisture.

#### 5. Indications for Use:

DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.

Premarket Notification

DURASHIELD® PLUS

DENTSPLY International

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#### ର. Substantial Equivalence:

Technological Characteristics.

The technological characteristics (i.e., chemical composition and device function) of DURASHIELD® PLUS are similar to that of Sci-Pharm DFV Varnish and other cavity varnishes that have been in widespread use for many decades. The only difference is that DURASHIELD® PLUS contains NovaMin, which naturally remineralizes teeth.

#### Non-Clinical Performance Data.

Prior use of the components of DURASHIELD® PLUS have been evaluated and passed biocompatibility testing for oral toxicity. Therefore, no additional biocompatibility tests were conducted.

### Conclusion as to Substantial Equivalence

DURASHIELD® PLUS with NovaMin is substantially equivalent to the current Sci-Pharm DFV Varnish in terms of intended use, physical properties and materials. The purpose of this submission is to introduce a cavity varnish with NovaMin.

Premarket Notification

DURASHIELD® PLUS

DENTSPLY International

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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 overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# OCT 2 9 2008

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K082198

Trade/Device Name: Durashield® Plus Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: July 31, 2008 Received: August 4, 2008

Dear Ms. Lewis:

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.

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

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours,

M. Nemelka-Lenderz for //

Chiu S. Lin, Ph. D Division 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 STATEMENT

K082198

510(k) Number (if known):

Device Name: DURASHIELD® PLUS

Indications for Use:

DURASHIELD® PLUS is indicated for the relief of dental hypersensitivity where dentin and cementum are exposed.

Prescription Use ਮੁ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (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)

Sagar Punno

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

510(k) Number: K952188