3M CLINPRO SEALANT

K992326 · 3M Company · EBC · Oct 8, 1999 · Dental

Device Facts

• Record ID: K992326
• Device Name: 3M CLINPRO SEALANT
• Applicant: 3M Company
• Product Code: EBC · Dental
• Decision Date: Oct 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Pit and fissure sealant.

Device Story

3M Clinpro Sealant is a single-part, light-curing dental material used as a pit and fissure sealant on posterior teeth. The device is applied by dental professionals in a clinical setting to prevent dental caries. It utilizes methacrylate resin chemistry, consistent with the predicate device. The sealant is not permanent. Clinical benefit is derived from the physical sealing of pits and fissures on posterior teeth to protect against decay.

Clinical Evidence

Bench testing only. Tests included shear bond strength, ambient light sensitivity, cure time, depth of cure, and uncured film thickness. The device meets ISO 6874-1988 standards for dental resin-based pit and fissure sealants.

Technological Characteristics

Single-part, light-curing methacrylate resin-based dental sealant. Complies with ISO 6874-1988. No electronic or software components.

Indications for Use

Indicated for use as a pit and fissure sealant on posterior teeth.

Regulatory Classification

Identification

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Predicate Devices

• 3M Concise Light Cure White Sealant

Submission Summary (Full Text)

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8 1999

OCT

### 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

| Name: | Lael J. Pickett<br>Regulatory Affairs Specialist |
|----------------------|-------------------------------------------------------------------------------------------|
| Address: | 3M Dental Products Laboratory<br>3M Center, Building 260-2B-12<br>St. Paul, MN 55144-1000 |
| Telephone: | 612-733-3594 |
| Fax: | 612-736-0990 |
| Trade Name: | 3MTM ClinproTM Sealant |
| Common Names: | Dental sealant, pit and fissure sealant. |
| Classification Name: | 21 CFR § 872.3765 Pit and fissure sealant, Class II |
| Predicate Devices: | 3MTM ConciseTM Light Cure White Sealant, 3M |

3M™ Clinpro™ Sealant is a single part, light curing, pit and fissure sealant. This device, as well as the predicate device, are based on methacrylate resin chemistry.

The 3M™ Clinpro™ Sealant can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.

3M™ Clinpro™ Sealant and the predicate device have similar technological characteristics as indicated by their methacrylate resin chemistry. This is further validated by the comparative results of the bench tests conducted. These tests include Shear Bond Strength, Ambient Light Sensitivity, Cure Time, Depth of Cure, and Uncured Film Thickness.

The 3M™ Clinpro™ Sealant also meets ISO 6874-1988 "Dental resin-based pit and fissure sealants".

Based on the conclusions drawn from the safety analysis conducted on this device and the results of the bench testing, 3M™ Clinpro™ Sealant is safe, effective and performs as well, or better, than the predicate device mentioned above.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of three lines that form the shape of a snake wrapped around a staff.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 0CT

Ms. Lael J. Pickett Regulatory Affairs Specialist 3M Company Dental Products Division 3M Center, Building 260-2B-12 St. Paul, Minnesota 55144-1000

Re: K992326

> 3M™ Clinpro™ Sealant Trade Name: Regulatory Class: II Product Code: EBC July 7, 1999 Dated: Received: July 12, 1999

#### Dear Ms. Pickett:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Ms. Pickett

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Susan Ransom

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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## Device Name:_3M™ Clinpro™ Sealant

Indications For Use: This device is indicated for:

Pit and fissure sealant .

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off) Pamilo. D. Second for Juson finning Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________