NRC NON-RINSE CONDITIONER

K992519 · Dentsply Intl. · EBC · Oct 22, 1999 · Dental

Device Facts

• Record ID: K992519
• Device Name: NRC NON-RINSE CONDITIONER
• Applicant: Dentsply Intl.
• Product Code: EBC · Dental
• Decision Date: Oct 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2

Intended Use

Used to clean instrumented enamel prior to restoration of tooth structure with selected dental adhesive and preventive dental materials.

Device Story

NRC Non-Rinse Conditioner is a dental etching/conditioning solution applied to instrumented enamel. The solution partially dissolves enamel minerals, creating micro-porosities that increase surface area. This process facilitates intimate contact and penetration of subsequently applied dental sealants or adhesive bonding agents, enhancing adhesion. The device is intended for use by dental professionals in a clinical setting. It serves as a preparatory step in restorative or preventive dental procedures, improving the bond between the tooth surface and restorative materials.

Clinical Evidence

No clinical data provided. Biocompatibility was evaluated using the Ames Mutagenicity Test, which found the device to be non-mutagenic.

Technological Characteristics

Chemical etching/conditioning solution. Components consist of materials previously used in legally marketed dental devices. No specific materials or standards (ASTM) provided. Standalone liquid application.

Indications for Use

Indicated for cleaning instrumented enamel prior to the application of dental adhesive and preventive dental materials in patients requiring tooth structure restoration.

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

• Caulk® Tooth Conditioner Liquid (Pre-1976 Device)

Submission Summary (Full Text)

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## 510(k) SUMMARY

DENTSPLY

NAME & ADDRESS:

DENTSPLY International

992510

OCT 2 2 1999

570 West College Avenue P.O. Box 872 York, PA 17405-0872 [phone] ax 777 854-2343 P. J. Lehn Telefax [phone]

CONTACT: P. Jeffery Lehn

DATE PREPARED:

| TRADE OR PROPRIETARY NAME: | NRC ^TM NON-RINSE CONDITIONER | |
|----------------------------|------------------------------------------|-----------------|
| COMMON OR USUAL NAME: | Tooth conditioner | |
| CLASSIFICATION NAME: | Conditioner, pit and fissure sealant and | 872.3765 |
| PREDICATE DEVICE: | Caulk® Tooth Conditioner Liquid | Pre-1976 Device |

DEVICE DESCRIPTION: NRC™ NON-RINSE CONDITIONER is a no-rinse etching/ conditioning solution for use on enamel with selected adhesive and preventive dental materials.

NRC ™ NON-RINSE CONDITIONER partially dissolves the minerals within the enamel. This partial dissolution results in increased surface area due to micro-porosities created in the affected substrates. This allows for more intimate contact and penetration of the sealant material with the tooth, increasing the potential for adhesion of the sealant. To aid in the adhesive bonding agent is applied to the acid treated surfaces.

INTENDED USE: Used to clean instrumented enamel prior to the application of selected dental adhesive and preventive dental materials.

TECHNOLOGICAL CHARACTERISTICS: All of the components found in NRC™ NON-RINSE CONDITIONER have been used in legally marketed devices.

NRC™ NON-RINSE CONDITIONER was evaluated by the Ames Mutagenicity Test and found to be non-mutagenic.

We believe that the prior use of the components of NRC™ NON-RINSE CONDITIONER in legally marketed devices, the biocompatibility testing, and the performance data provided support the safety and effectiveness of NRC™ NON-RINSE CONDITIONER for the indicated uses.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes resembling a bird or abstract human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 1999

Mr. P. Jeffery Lehn Director, Corporate Compliance and Requlatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, PA 17405-0872

K992519 Re : NRC™ Non-Rinse Conditioner Trade Name: Requlatory Class: II Product Code: EBC Dated: July 27 1999

Received: July 28, 1999

Dear Mr. Lehn:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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. ਸੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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

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Page 2 - Mr. Lehn

the Federal Register. Please note: this response to your premarket notification submission does not affect any 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 diaqnostic 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 Runnes

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

Enclosure

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## PREMARKET NOTIFICATION

## INDICATIONS FOR USE STATEMENT

(As Required by 21 CFR 801.109)

510(K) Number:

8992519

Device Name:

NRC™ NON-RINSE CONDITIONER

Used to clean instrumented enamel prior to restoration of tooth structure with selected dental adhesive and preventive dental materials.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use _

Susan Russo

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number

000007