CAPO BULK FILL

K152471 · Schuetz Dental GmbH · EBF · Aug 4, 2016 · Dental

Device Facts

• Record ID: K152471
• Device Name: CAPO BULK FILL
• Applicant: Schuetz Dental GmbH
• Product Code: EBF · Dental
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Fillings with layer thicknesses up to 4 mm in Black's class I and II cavities Cavity lining - as a first (bottom) layer in Black's class I and II cavities

Device Story

Capo Bulk Fill is a light-cured, radiopaque, composite restorative material. Used by dental professionals in clinical settings for direct restorations. Applied to Black's class I and II cavities; allows bulk placement in layers up to 4 mm thick. Functions as a restorative filling or cavity liner. Provides structural repair and aesthetic restoration of tooth anatomy. Benefits patient by reducing clinical time through bulk-fill capability compared to traditional incremental layering techniques.

Clinical Evidence

Bench testing only. Performance evaluated via physical and chemical property testing, including radiopacity, depth of cure, and biocompatibility, confirming equivalence to predicate.

Technological Characteristics

Light-cured, methacrylate-based resin composite. Contains inorganic fillers for radiopacity. Formulated for bulk-fill application (up to 4 mm depth). Supplied as a paste for direct placement. Polymerization initiated by external dental curing light.

Indications for Use

Indicated for dental patients requiring restorations in Black's class I and II cavities, specifically for fillings up to 4 mm thickness or as a cavity lining (first/bottom layer).

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.

Predicate Devices

• Tetric N-Ceram Bulk Fill (K112656)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is the Department of Health and Human Services logo, which consists of a stylized caduceus symbol.

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

August 4, 2016

Schuetz Dental Gmbh Anke Puent Official Correspondent Dieselstr. 5- 6 Rosbach, 61191 DE

Re: K152471

Trade/Device Name: Capo Bulk Fill Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: August 25, 2015 Received: August 31, 2015

Dear Anke Puent:

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 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 Ruina DDS, MA

Tina Kiang Acting Division Director Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices

Enclosure

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## Indications for Use

510(k) Number (if known): K152471/S001 Device Name: Capo Bulk Fill Indications for Use:

- Fillings with layer thicknesses up to 4 mm in Black's class I and II cavities
- Cavity lining - as a first (bottom) layer in Black's class I and II cavities

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | <div> <span style="text-decoration: underline;">✓</span> </div> |
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AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | <div> <span style="text-decoration: underline;"></span> </div> |
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)

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