PRISMATIK CLINICAL ZIRCONIA

Powder, Porcelain

GLIDEWELL LABORATORIES

The following data is part of a premarket notification filed by Glidewell Laboratories with the FDA for Prismatik Clinical Zirconia.

Pre-market Notification Details

• Device ID: K060104
• 510k Number: K060104
• Device Name: PRISMATIK CLINICAL ZIRCONIA
• Classification: Powder, Porcelain
• Applicant: GLIDEWELL LABORATORIES 4141 MACARTHUR BLVD. Newport Beach, CA 92660
• Contact: Keith D Allred
• Correspondent: Keith D Allred; GLIDEWELL LABORATORIES 4141 MACARTHUR BLVD. Newport Beach, CA 92660
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-01-13
• Decision Date: 2006-03-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D745701010BRX00140	K060104	000
D745701010BRX01760	K060104	000
D745701010BRX01750	K060104	000
D745701010BRX01740	K060104	000
D745701010BRX01730	K060104	000
D745701010BRX01650	K060104	000
D745701010BRX01640	K060104	000
D745701010BRX01530	K060104	000
D745701010BRX01050	K060104	000
D745701010BRX01770	K060104	000
D745701010BRX01780	K060104	000
D745701010BRX01860	K060104	000
D745701010BRX01850	K060104	000
D745701010BRX01840	K060104	000
D745701010BRX01830	K060104	000
D745701010BRX01820	K060104	000
D745701010BRX01810	K060104	000
D745701010BRX01800	K060104	000
D745701010BRX01790	K060104	000
D745701010BRX00970	K060104	000
D745701010BRX00950	K060104	000
D745701010BRX00320	K060104	000
D745701010BRX00280	K060104	000
D745701010BRX00260	K060104	000
D745701010BRX00250	K060104	000
D745701010BRX00240	K060104	000
D745701010BRX00190	K060104	000
D745701010BRX00160	K060104	000
D745701010BRX00150	K060104	000
D745701010BRX00340	K060104	000
D745701010BRX00360	K060104	000
D745701010BRX00920	K060104	000
D745701010BRX00530	K060104	000
D745701010BRX00520	K060104	000
D745701010BRX00510	K060104	000
D745701010BRX00500	K060104	000
D745701010BRX00440	K060104	000
D745701010BRX00420	K060104	000
D745701010BRX00400	K060104	000
D745701010BRX01870	K060104	000
D745701010BRX01880	K060104	000
D745701010BRX01890	K060104	000
D745701015BRX00070	K060104	000
D745701015BRX00060	K060104	000
D745701015BRX00050	K060104	000
D745701015BRX00040	K060104	000
D745701015BRX00030	K060104	000
D745701015BRX00020	K060104	000
D745701015BRX00010	K060104	000
D745701013BRX00160	K060104	000
D745701015BRX00080	K060104	000
D745701015BRX00090	K060104	000
D745701130BRX00010	K060104	000
D745701015BRX00160	K060104	000
D745701015BRX00150	K060104	000
D745701015BRX00140	K060104	000
D745701015BRX00130	K060104	000
D745701015BRX00120	K060104	000
D745701015BRX00110	K060104	000
D745701015BRX00100	K060104	000
D745701013BRX00150	K060104	000
D745701013BRX00140	K060104	000
D745701013BRX00030	K060104	000
D745701013BRX00020	K060104	000
D745701013BRX00010	K060104	000
D745701010BRX01940	K060104	000
D745701010BRX01930	K060104	000
D745701010BRX01920	K060104	000
D745701010BRX01910	K060104	000
D745701010BRX01900	K060104	000
D745701013BRX00040	K060104	000
D745701013BRX00050	K060104	000
D745701013BRX00130	K060104	000
D745701013BRX00120	K060104	000
D745701013BRX00110	K060104	000
D745701013BRX00100	K060104	000
D745701013BRX00090	K060104	000
D745701013BRX00080	K060104	000
D745701013BRX00070	K060104	000
D745701013BRX00060	K060104	000
D745701130BRX00020	K060104	000