Clip Flow

K153493 · Voco GmbH · EBF · Jul 29, 2016 · Dental

Device Facts

• Record ID: K153493
• Device Name: Clip Flow
• Applicant: Voco GmbH
• Product Code: EBF · Dental
• Decision Date: Jul 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Clip Flow is intended for use as: [A] Temporary inlay and onlay treatments of the cavity [B] Sealing of openings for implant screws [C] Relining material for temporary crowns and bridges [D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions [E] Covering of the gingival margin [F] Fixing of resin matrix during filling placement [G] Temporary filling of cavities

Device Story

Clip Flow is a light-cured, resin-based dental material used by dentists for temporary restorative and procedural applications. It functions as a temporary inlay/onlay, sealant for implant screw access, relining material for temporary crowns/bridges, block-out material for dental impressions, gingival margin cover, and resin matrix stabilizer. The material is applied directly to the dental site and cured. It provides a temporary barrier or structural support during dental procedures, facilitating clinical workflows and protecting the treatment area until permanent restoration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Light-cured resin-based dental material. Classified as a tooth shade resin material (21 CFR 872.3690). Formulated for temporary dental applications. No electronic components, software, or complex mechanical sensing.

Indications for Use

Indicated for dental patients requiring temporary cavity restorations, sealing of implant screw access, relining of temporary crowns/bridges, blocking out retentive areas, covering gingival margins, or fixing resin matrices during restorative procedures.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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

July 29, 2016

Voco Gmbh T Gerkensmeier Regulatory Affairs Anton-flettner-str. 1-3 Cuxhaven, 27472 DE

Re: K153493

Trade/Device Name: Clip Flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 1, 2015 Received: December 4, 2015

Dear T 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Runno DDS, MA

Erin Keith 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: 2000 - 1000 Device Name: Clip Flow Indications for Use: Clip Flow is intended for use as: [A] Temporary inlay and onlay treatments of the cavity [B] Sealing of openings for implant screws [C] Relining material for temporary crowns and bridges [D] Block-out material for retentive areas in the dental arch, e.g. before taking impressions [E] Covering of the gingival margin [F] Fixing of resin matrix during filling placement [G] Temporary filling of cavities 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)