SYNERGY

Material, Tooth Shade, Resin

COLTENE/WHALEDENT INC.

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

Pre-market Notification Details

• Device ID: K974465
• 510k Number: K974465
• Device Name: SYNERGY
• Classification: Material, Tooth Shade, Resin
• Applicant: COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009
• Contact: H.j. Volgelstein
• Correspondent: H.j. Volgelstein; COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-11-26
• Decision Date: 1998-03-09

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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J00612210	K974465	000
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