CONTROL SEAL

K130485 · Voco GmbH · EBC · Feb 11, 2014 · Dental

Device Facts

• Record ID: K130485
• Device Name: CONTROL SEAL
• Applicant: Voco GmbH
• Product Code: EBC · Dental
• Decision Date: Feb 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3765
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Sealing / filling of pits and fissures Sealing / facing of damaged enamel surfaces Covering of predilection sites, e.g., within the scope of orthodontic treatments Sealing of composite or glass ionomer fillings (profective layer against moisture) Sealing of deciduous teeth Extended fissure sealing

Device Story

Control Seal is a dental material used for sealing and filling pits and fissures, damaged enamel, and restorative materials. It acts as a protective layer against moisture for composite or glass ionomer fillings and is used for extended fissure sealing and deciduous teeth. The device is applied by dental professionals in a clinical setting. It functions as a physical barrier to prevent caries and protect dental surfaces. The output is a cured sealant layer that improves the longevity of restorations and protects vulnerable tooth structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental pit and fissure sealant and conditioner. Class II device (21 CFR 872.3765). Product code EBC.

Indications for Use

Indicated for sealing and filling pits and fissures, facing damaged enamel, covering predilection sites during orthodontic treatment, sealing composite or glass ionomer fillings against moisture, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

February 11, 2014

VOCO GmbH Dr. Thorsten Gerkensmeier Regulatory Affairs Anton-Flettner-Strasse 1-3 D-27472 Cuxhaven GERMANY

Re: K130485

Trade/Device Name: Control Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and Fissure Sealant and Conditioner Regulatory Class: II Product Code: EBC Dated: January 9, 2014 Received: January 14, 2014

Dear Dr. Gerkensmeier:

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. 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.

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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 (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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for

Erin I. Keith, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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: Control Seal Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: - Sealing / filling of pits and fissures - Sealing / facing of damaged enamel surfaces - Covering of predilection sites, e.g., within the scope of orthodontic treatments - Sealing of composite or glass ionomer fillings (profective layer against moisture) - Sealing of deciduous teeth - Extended fissure sealing OR Over-The-Counter Use _ Prescription Use X (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan R. Mary S. Runner -S
DOS/M 2014.01.28
14:00:05'05'00'