DENTIN DESENSITIZER AGENT
Device Facts
| Record ID | K073117 |
|---|---|
| Device Name | DENTIN DESENSITIZER AGENT |
| Applicant | Dentsply Intl., Inc. |
| Product Code | LBH · Dental |
| Decision Date | Dec 19, 2007 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3260 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The DENTIN DESENSITIZER AGENT is intended for treating and preventing dentinal hypersensitivity. The Agent can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
Device Story
Dentin Desensitizer Agent is a chair-side dental material used by clinicians to treat and prevent dentinal hypersensitivity. Applied to tooth surfaces under direct or indirect restorations or to areas of cervical sensitivity. Device functions as a desensitizing agent to mitigate patient pain. Safety and effectiveness established through biocompatibility testing and comparison to legally marketed predicate devices.
Clinical Evidence
Bench testing only. Biocompatibility testing performed including agar overlay cytotoxicity, intracutaneous irritation, and systemic toxicity.
Technological Characteristics
Chair-side dental desensitizing agent. Components consist of materials previously used in legally marketed dental devices. Evaluated via biocompatibility testing (cytotoxicity, irritation, systemic toxicity).
Indications for Use
Indicated for the treatment and prevention of dentinal hypersensitivity. Applicable for use under direct or indirect dental restorations and for cervical sensitivity.
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
Submission Summary (Full Text)
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K073117
## 510(k) SUMMARY
DEC 1 9 2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
| CONTACT: | Helen Lewis |
|----------------------------|----------------------------------------------------------------|
| DATE PREPARED: | November 1, 2007 |
| TRADE OR PROPRIETARY NAME: | DENTIN DESENSITIZER AGENT |
| CLASSIFICATION NAME: | Resin Tooth Bonding Agent 872.3200 |
| PREDICATE DEVICES: | Gluma Desensitizer<br>K962812<br>Quell Desensitizer<br>K010957 |
DEVICE DESCRIPTION: The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.
The DENTIN DESENSITIZER AGENT is intended for treating and INTENDED USE: preventing dentinal hypersensitivity. The Agent can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in DENTIN DESENSITIZER AGENT have been used in legally marketed devices and/or were found safe for dental use. The DENTIN DESENSITIZER AGENT has been evaluated and passed biocompatibility testing for agar overlay cytotoxicity, intracutaneous irritation, and systemic toxicity.
We believe that the prior use of the components of DENTIN DESENSITIZER AGENT in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of DENTIN DESENSITIZER AGENT for the indicated uses.
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## DEC 1 9 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International, Incorporated Susquehanna Commerce Center 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404
Re: K073117
Trade/Device Name: Dentin Desensitizer Agent Regulation Number: 21 CFR 872.3260 Regulation Name: Cavity Varnish Regulatory Class: II Product Code: LBH Dated: November 1, 2007 Received: November 5, 2007
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. 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
510(k) Number (if known): K073117
Device Name:
DENTIN DESENSITIZER AGENT
Indications for Use:
Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.
Prescription Use X (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)
Suren Rumpe
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: k672117
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