OBSIDIAN PRESS (ALL CERAMIC AND POM)

Powder, Porcelain

PRISMATIK DENTALCRAFT, INC.

The following data is part of a premarket notification filed by Prismatik Dentalcraft, Inc. with the FDA for Obsidian Press (all Ceramic And Pom).

Pre-market Notification Details

• Device ID: K141887
• 510k Number: K141887
• Device Name: OBSIDIAN PRESS (ALL CERAMIC AND POM)
• Classification: Powder, Porcelain
• Applicant: PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine, CA 92612
• Contact: Armin Zehtabchi
• Correspondent: Armin Zehtabchi; PRISMATIK DENTALCRAFT, INC. 2212 DUPONT DRIVE, SUITE P Irvine, CA 92612
• Product Code: EIH
• CFR Regulation Number: 872.6660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-07-14
• Decision Date: 2014-11-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D745701121OBP01321	K141887	000
D745701121OBP01211	K141887	000
D745701121OBP01201	K141887	000
D745701121OBP01191	K141887	000
D745701121OBP01181	K141887	000
D745701121OBP01171	K141887	000
D745701121OBP01161	K141887	000
D745701121OBP01151	K141887	000
D745701121OBP01141	K141887	000
D745701121OBP01221	K141887	000
D745701121OBP01231	K141887	000
D745701121OBP01311	K141887	000
D745701121OBP01301	K141887	000
D745701121OBP01291	K141887	000
D745701121OBP01281	K141887	000
D745701121OBP01271	K141887	000
D745701121OBP01261	K141887	000
D745701121OBP01251	K141887	000
D745701121OBP01241	K141887	000
D745701121OBP01131	K141887	000
D745701121OBP01121	K141887	000
D745701121OBP01111	K141887	000
D745701121OBP01001	K141887	000
D745701121OBP00991	K141887	000
D745701121OBP00981	K141887	000
D745701121OBP00971	K141887	000
D745701121OBP00961	K141887	000
D745701121OBP00951	K141887	000
D745701121OBP00931	K141887	000
D745701121OBP00921	K141887	000
D745701121OBP01011	K141887	000
D745701121OBP01021	K141887	000
D745701121OBP01101	K141887	000
D745701121OBP01091	K141887	000
D745701121OBP01081	K141887	000
D745701121OBP01071	K141887	000
D745701121OBP01061	K141887	000
D745701121OBP01051	K141887	000
D745701121OBP01041	K141887	000
D745701121OBP01031	K141887	000
D745701121OBP00911	K141887	000
D745701121OBP01331	K141887	000
D745701121OBP01741	K141887	000
D745701121OBP01631	K141887	000
D745701121OBP01621	K141887	000
D745701121OBP01611	K141887	000
D745701121OBP01601	K141887	000
D745701121OBP01591	K141887	000
D745701121OBP01581	K141887	000
D745701121OBP01571	K141887	000
D745701121OBP01561	K141887	000
D745701121OBP01641	K141887	000
D745701121OBP01651	K141887	000
D745701121OBP01731	K141887	000
D745701121OBP01721	K141887	000
D745701121OBP01711	K141887	000
D745701121OBP01701	K141887	000
D745701121OBP01691	K141887	000
D745701121OBP01681	K141887	000
D745701121OBP01671	K141887	000
D745701121OBP01661	K141887	000
D745701121OBP01551	K141887	000
D745701121OBP01541	K141887	000
D745701121OBP01531	K141887	000
D745701121OBP01421	K141887	000
D745701121OBP01411	K141887	000
D745701121OBP01401	K141887	000
D745701121OBP01391	K141887	000
D745701121OBP01381	K141887	000
D745701121OBP01371	K141887	000
D745701121OBP01361	K141887	000
D745701121OBP01351	K141887	000
D745701121OBP01431	K141887	000
D745701121OBP01441	K141887	000
D745701121OBP01521	K141887	000
D745701121OBP01511	K141887	000
D745701121OBP01501	K141887	000
D745701121OBP01491	K141887	000
D745701121OBP01481	K141887	000
D745701121OBP01471	K141887	000
D745701121OBP01461	K141887	000
D745701121OBP01451	K141887	000
D745701121OBP01341	K141887	000