SILVER DENTAL ARREST

K102973 · Cooley Consulting, Inc. · PHR · Jul 31, 2014 · Dental

Device Facts

• Record ID: K102973
• Device Name: SILVER DENTAL ARREST
• Applicant: Cooley Consulting, Inc.
• Product Code: PHR · Dental
• Decision Date: Jul 31, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3260
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Treatment of Dental Hypersensitivity. For use in adults over the age of 21.

Device Story

Silver Dental Arrest is a dental material used for the treatment of dental hypersensitivity. It is applied by a dental professional in a clinical setting. The device acts as a cavity varnish to address sensitivity issues in adult patients. It is intended for prescription use only.

Technological Characteristics

Classified as a cavity varnish under 21 CFR 872.3620 (Product Code PHR).

Indications for Use

Indicated for the treatment of dental hypersensitivity in adults over the age of 21.

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.

Public Health Service

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

July 31, 2014

ADP Silver Dental Arrest, LLC C/O William E. Cooley, Ph.D., RAC President Cooley Consulting, Inc. 531 Chisholm Trail Wyoming. OH 45215

Re: K102973

> Trade/Device Name: Silver Dental Arrest Regulation Number: 21 CFR 872.3620 Regulation Name: Cavity Varnish Regulatory Class: Class II Product Code: PHR Dated: April 19, 2014 Received: April 22, 2014

Dear Dr. Cooley:

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 10 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.

{1}------------------------------------------------

## Page 2 - Dr. Cooley

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 (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 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,

## Mary S. Runner -S

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

{2}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|-----------------------------------------|-----------------------------------------------------------------------------|
| Food and Drug Administration | |
| <b>Indications for Use</b> | |
| | Form Approved: OMB No. 0910-0120 |
| | Expiration Date: January 31, 2017 |
| | See PRA Statement below. |
| 510(k) Number ( <i>If known</i> ) | K102973 |
| Device Name | Silver Dental Arrest |
| Indications for Use ( <i>Describe</i> ) | Treatment of Dental Hypersensitivity. For use in adults over the age of 21. |

Type of Use (*Select one or both, as applicable*)

| <span style="display:inline-block; margin-right: 5px;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block; margin-right: 5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (*Signature*)

Sheena A. Green -S

2014.07.30 14:01:58 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review Instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this Information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[[e-mail]](mailto:[e-mail])

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."*