BruxZir Esthetic

Powder, Porcelain

Prismatik Dentalcraft, Inc.

The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Bruxzir Esthetic.

Pre-market Notification Details

• Device ID: K213425
• 510k Number: K213425
• Device Name: BruxZir Esthetic
• Classification: Powder, Porcelain
• Applicant: Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 96212
• Contact: So Hyun Park
• Correspondent: So Hyun Park; Prismatik Dentalcraft, Inc. 2144 Michelson Drive Irvine, CA 96212
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-10-21
• Decision Date: 2021-11-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D745701183BEP00490	K213425	000
D745701183BEP00620	K213425	000
D745701183BEP00630	K213425	000
D745701183BEP00640	K213425	000
D745701183BEP00650	K213425	000
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D745701183BEP00670	K213425	000
D745701183BEP00680	K213425	000
D745701183BEP00690	K213425	000
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D745701183BEP00190	K213425	000
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D745701183BEP00390	K213425	000
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D745701183BEP01600	K213425	000
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D745701183BEP01430	K213425	000
D745701183BEP00960	K213425	000
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D745701183BEP01110	K213425	000
D745701183BEP01120	K213425	000
D745701183BEP01130	K213425	000
D745701183BEP01140	K213425	000
D745701183BEP01150	K213425	000
D745701183BEP01160	K213425	000
D745701183BEP01170	K213425	000
D745701183BEP01080	K213425	000
D745701183BEP01070	K213425	000
D745701183BEP01060	K213425	000
D745701183BEP00970	K213425	000
D745701183BEP00980	K213425	000
D745701183BEP00990	K213425	000
D745701183BEP01000	K213425	000
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D745701183BEP01030	K213425	000
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D745701183BEP01190	K213425	000
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D745701183BEP01420	K213425	000