NUANCE

Material, Tooth Shade, Resin

DISCUS DENTAL, LLC

The following data is part of a premarket notification filed by Discus Dental, Llc with the FDA for Nuance.

Pre-market Notification Details

• Device ID: K101215
• 510k Number: K101215
• Device Name: NUANCE
• Classification: Material, Tooth Shade, Resin
• Applicant: DISCUS DENTAL, LLC 8550 HIGUERA ST. Culver City, CA 90232
• Contact: Winkie Wong
• Correspondent: Casey Conry; UNDERWRITERS LABORATORIES, INC. 1285 WALT WHITMAN RD. Melville, NY 11747
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2010-04-30
• Decision Date: 2010-05-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D813CR11550	K101215	000
D813CR11020	K101215	000
D813CR11030	K101215	000
D813CR11040	K101215	000
D813CR11060	K101215	000
D813CR11080	K101215	000
D813CR11090	K101215	000
D813CR11120	K101215	000
D813CR11210	K101215	000
D813CR11350	K101215	000
D813CR11360	K101215	000
D813CR11370	K101215	000
D813CR11380	K101215	000
D813CR11400	K101215	000
D813CR11420	K101215	000
D813CR11430	K101215	000
D813CR11460	K101215	000
D813CR11010	K101215	000