COMPONEER

K112168 · Coltene/Whaledent AG · EBF · Nov 21, 2011 · Dental

Device Facts

• Record ID: K112168
• Device Name: COMPONEER
• Applicant: Coltene/Whaledent AG
• Product Code: EBF · Dental
• Decision Date: Nov 21, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

COMPONEER are polymerised, radio-opaque composite shells that are indicated for -restoration therapy for caries -optimisation of old restorations -tooth fractures -extending incisors -malpositioned teeth -tooth discoloration, incorrect shading -anatomical malformation -diasteme -attrition, abrasion, erosion -cosmetic correction

Device Story

COMPONEER are pre-fabricated, polymerized, radio-opaque composite shells used by dentists for direct restorative and cosmetic procedures. The shells are applied to the tooth surface to address conditions such as caries, fractures, malpositioned teeth, discoloration, and wear. The device functions as a restorative material, providing a pre-formed anatomical shape that the clinician bonds to the tooth structure. This simplifies the restoration process compared to traditional free-hand composite layering. The output is a restored or aesthetically corrected tooth surface. Used in dental clinics by licensed practitioners.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Polymerized, radio-opaque composite shells. Pre-fabricated form factor for direct dental application. Material composition is a dental composite resin.

Indications for Use

Indicated for patients requiring dental restoration or cosmetic correction of teeth due to caries, fractures, malposition, discoloration, anatomical malformation, diastema, or wear (attrition, abrasion, erosion).

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

·Coltene/Whaledent AG C/O Mr. Mark Van Meter Senior Regualtory Affairs Specialist 235 Ascot Parkway Cuyahoga Falls, Ohio 44223

NOV 2 1 2011

Re: K112168

Trade/Device Name: COMPONEER Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: November 11, 2011 Received: November 14, 2011

Dear Mr. Meter:

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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Page 2- Mr. Meter

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

f. Syren Simmons
Anthony D. Watson, R.S.

Anthony D. Watson, B.S., M.S., M.B.A. 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): | K112168 |
| Device Name: | COMPONEER |

Indications for use: COMPONEER are polymerised, radio-opaque composite shells that are indicated for

- -restoration therapy for caries
- -optimisation of old restorations
- -tooth fractures
- -extending incisors
- -malpositioned teeth
- -tooth discoloration, incorrect shading
- -anatomical malformation
- -diasteme
- -attrition, abrasion, erosion
- -cosmetic correction

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

Prescription Use X · (Part 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Susa Quaser

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

510(k) Number: K41216x

Coltène/Whaledent AG Feldwiesenstrasse 20 9450 Alstätten Switzerland Phone [phone] Fax [phone] E-Mail [e-mail]