CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)

Material, Tooth Shade, Resin

PRISMATIK DENTALCRAFT, INC.

The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Camouflage Nanohybrid Composite (universal & Flowable).

Pre-market Notification Details

• Device ID: K133850
• 510k Number: K133850
• Device Name: CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE)
• Classification: Material, Tooth Shade, Resin
• Applicant: PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, STE IJK Irvine, CA 92612
• Contact: Armin Zehtabchi
• Correspondent: Armin Zehtabchi; PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, STE IJK Irvine, CA 92612
• Product Code: EBF
• CFR Regulation Number: 872.3690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-12-19
• Decision Date: 2014-06-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D745701151CMU00010	K133850	000
D745701151CMU00170	K133850	000
D745701151CMU00180	K133850	000
D745701151CMU00190	K133850	000
D745701151CMU00200	K133850	000
D745701151CMU00210	K133850	000
D745701151CMU00221	K133850	000
D745701151CMU00231	K133850	000
D745701151CMU00241	K133850	000
D745701151CMU00251	K133850	000
D745701151CMU00261	K133850	000
D745701151CMU00271	K133850	000
D745701151CMU00281	K133850	000
D745701151CMU00291	K133850	000
D745701151CMU00160	K133850	000
D745701151CMU00150	K133850	000
D745701151CMU00020	K133850	000
D745701151CMU00030	K133850	000
D745701151CMU00040	K133850	000
D745701151CMU00050	K133850	000
D745701151CMU00060	K133850	000
D745701151CMU00070	K133850	000
D745701151CMU00080	K133850	000
D745701151CMU00090	K133850	000
D745701151CMU00100	K133850	000
D745701151CMU00110	K133850	000
D745701151CMU00120	K133850	000
D745701151CMU00130	K133850	000
D745701151CMU00140	K133850	000
D745701151CMU00301	K133850	000
D745701151CMU00311	K133850	000
D745701151CMU00321	K133850	000
D745701152CMF00050	K133850	000
D745701152CMF00060	K133850	000
D745701152CMF00070	K133850	000
D745701152CMF00080	K133850	000
D745701152CMF00090	K133850	000
D745701152CMF00101	K133850	000
D745701152CMF00111	K133850	000
D745701152CMF00121	K133850	000
D745701152CMF00131	K133850	000
D745701152CMF00141	K133850	000
D745701152CMF00151	K133850	000
D745701152CMF00161	K133850	000
D745701152CMF00171	K133850	000
D745701152CMF00040	K133850	000
D745701152CMF00030	K133850	000
D745701151CMU00331	K133850	000
D745701151CMU00341	K133850	000
D745701151CMU00351	K133850	000
D745701151CMU00361	K133850	000
D745701151CMU00371	K133850	000
D745701151CMU00381	K133850	000
D745701151CMU00391	K133850	000
D745701151CMU00401	K133850	000
D745701151CMU00411	K133850	000
D745701151CMU00421	K133850	000
D745701151CMU00451	K133850	000
D745701152CMF00010	K133850	000
D745701152CMF00020	K133850	000
D745701152CMF00181	K133850	000