GRANDIO SEAL

K062344 · Voco GmbH · EBC · Oct 2, 2006 · Dental

Device Facts

• Record ID: K062344
• Device Name: GRANDIO SEAL
• Applicant: Voco GmbH
• Product Code: EBC · Dental
• Decision Date: Oct 2, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing of damaged enamel surfaces, covering of caries predilection sites during or damaged composite or coment fillings (redilection sites during orthodontic treatment, sealing of composite or cement filling of cance production sites uning of modeling of decident, sealing of deciduous teeth.

Device Story

Grandio Seal is a dental material used by clinicians to seal or fill pits and fissures, repair damaged enamel, and protect caries-prone sites during orthodontic treatment. It is applied to deciduous and permanent teeth to prevent decay. The device functions as a physical barrier, sealing composite or cement fillings and enamel surfaces. It is intended for professional use in a dental clinic setting.

Clinical Evidence

bench testing only

Technological Characteristics

Pit and fissure sealant and conditioner; Class II device; Product Code EBC.

Indications for Use

Indicated for sealing/filling pits and fissures, sealing/facing damaged enamel, covering caries-prone sites during orthodontic treatment, and sealing deciduous 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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT == 2 2006

Dr. Michael Sues Mgr. for Regulatory Affairs Voco GmbH Anton-Flettner-St. 1-3 Cuxhaven, GERMANY D-27472

Re: K062344

Trade/Device Name: Grandio Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: August 7, 2006 Received: August 11, 2006

Dear Dr. Sues:

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. Sues

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/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: _

Device Name: Grandio Seal

Indications for Use:

Grandio Seal is intended for sealing/filling of pits and fissures, sealing/facing of damaged enamel surfaces, covering of caries predilection sites during or damaged
composite or coment fillings (redilection sites during orthodontic treatment, sealing of composite or cement filling of cance production sites uning of modeling of decident, sealing of deciduous teeth.

Prescription Use __X

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Punson

: ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------of Anasmesiology, General Hospital, n Control, Dental Devices

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