COMPONEER

Material, Tooth Shade, Resin

COLTENE/WHALEDENT AG

The following data is part of a premarket notification filed by Coltene/whaledent Ag with the FDA for Componeer.

Pre-market Notification Details

• Device ID: K112168
• 510k Number: K112168
• Device Name: COMPONEER
• Classification: Material, Tooth Shade, Resin
• Applicant: COLTENE/WHALEDENT AG 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223
• Contact: Mark Van Meter
• Correspondent: Mark Van Meter; COLTENE/WHALEDENT AG 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-07-28
• Decision Date: 2011-11-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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