S&C-SELF ETCH PR-BOND

K042614 · S & C Polymer GmbH · KLE · Nov 22, 2004 · Dental

Device Facts

• Record ID: K042614
• Device Name: S&C-SELF ETCH PR-BOND
• Applicant: S & C Polymer GmbH
• Product Code: KLE · Dental
• Decision Date: Nov 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

S&C Self Etch Primebond is intended for bonding composites, compomers, and resin modified glass ionomer cements to enamel and dentin.

Device Story

S&C Self Etch Primebond is a dental resin bonding agent. It is applied by dental professionals to enamel and dentin surfaces to facilitate the adhesion of restorative materials, including composites, compomers, and resin-modified glass ionomer cements. The device functions as a chemical interface to improve bond strength between the tooth structure and the restorative material. It is used in a clinical dental setting. The product is supplied for professional use to assist in dental restorations, providing a benefit by ensuring the retention and stability of the restorative material within the tooth cavity.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on bench testing and regulatory review.

Technological Characteristics

Resin tooth bonding agent; Class II device; Product Code KLE; 21 CFR 872.3200.

Indications for Use

Indicated for bonding composites, compomers, and resin modified glass ionomer cements to enamel and dentin in dental patients.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 2 2004

Dr. Christian Boettcher Regulatory Compliance Officer S&C Polymer GmbH Robert-Bosch-Straße 5 D-25335 Elmshorn GERMANY

Re: K042614

Trade/Device Name: S&C Self Etch Primebond Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 22, 2004 Received: September 24, 2004

Dear Dr. Boettcher:

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 - Dr. Christian Boettcher

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 (OS) 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

Signature

Chiu S. Lin, PhD 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

510(k) Number (if known): K042614

Device Name: S&C Self Etch Primebond Indications for Use:

S&C Self Etch Primebond is intended for bonding composites, compomers, and resin modified glass ionomer cements to enamel and dentin.

Prescription Use X (21 CFR Part 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR Part 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susa Russe

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

510(k) Number: _

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