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PRISMATIK DENTALCRAFT, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2144 Michelson Drive, Irvine, CA, 92612
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3011649314
DUNS Number: —

Catalogue (5582)

Page 13 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1070-IMP0030	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0216	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0022	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0449	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0385	FDA UDI	Class II	Active
BruxZir	4400178	FDA UDI	Class II	Active
Inclusive	70-1173-COM0021	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0025	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0102	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0054	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0042	FDA UDI	Class I	Active
BruxZir	70-1159-BXA0005	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0004	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0160	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0313	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0330	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0006	FDA UDI	Class II	Active
Hahn	70-1153-PRA0054	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0937	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0211	FDA UDI	Class I	Active
Inclusive	70-1053-COM0062	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0023	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0053	FDA UDI	Class I	Active
Inclusive	70-1048-COM0068	FDA UDI	Class I	Active
Inclusive®	70-1194-COM0026	FDA UDI	Class I	Active
fastscan.io	70-1181-MIL0152	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0020	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0560	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0032	FDA UDI	Class II	Active
Hahn	70-1071-SRG0083	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRS0002	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0553	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0045	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0120	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0170	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0056	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0162	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0053	FDA UDI	Class I	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0037	FDA UDI	Class II	Active
Inclusive	70-1054-COM0067	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0016	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0022	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0005	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0059	FDA UDI	Class II	Active
Inclusive	70-1047-COM0166	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0926	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0396	FDA UDI	Class II	Active
Inclusive	70-1047-COM0114	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0212	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0096	FDA UDI	Class II	Active

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FDA Recalls (3)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 30, 2025	Z-0417-2026	—	open, classified	Incorrect titanium screw, packaged with dental implant.
Apr 14, 2025	Z-1856-2025	—	open, classified	Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
Aug 15, 2016	Z-2897-2016	—	terminated	Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.