COMPONEER

• K Number: K112168
• Device Name: COMPONEER
• Manufacturer: COLTENE/WHALEDENT AG
• Date Cleared: 2011-11-21 ( 116 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: K191385

Intended Use

• -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 Description

COMPONEER are polymerised, radio-opaque composite shells

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding a dental device called COMPONEER. It does not contain information about the acceptance criteria or a study proving the device meets said criteria for an AI/ML powered medical device.

The document states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination based on comparing the new device to existing ones, rather than through a study with specified acceptance criteria for algorithm performance.

Therefore, I cannot extract the requested information from this document.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is facing to the right.

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]

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
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.(b)
Classification. Class II.