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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 92 of 112

Device	Model / Reference	Registries	Class	Status
Obsidian	70-1124-SHS0024	FDA UDI	Class II	Unknown
BruxZir	70-1118-BXS0121	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0159	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0429	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0446	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0056	FDA UDI	Class I	Active
Hahn	70-1071-SRG0206	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0003	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0064	FDA UDI	Class I	Active
Inclusive	70-1054-COM0111	FDA UDI	Class I	Active
Obsidian	70-1124-SHS0046	FDA UDI	Class II	Unknown
Hahn	70-1153-PRS0012	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0113	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0099	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0810	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0116	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0070	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0088	FDA UDI	Class I	Active
Inclusive	70-1051-COM0088	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0102	FDA UDI	Class I	Active
Inclusive®	70-1052-COM0166	FDA UDI	Class I	Active
Inclusive	70-1053-COM0038	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0011	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0056	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0283	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0118	FDA UDI	Class II	Active
Hahn	70-1153-PRA0019	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0042	FDA UDI	Class I	Active
Obsidian	70-1122-OMB0153	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0057	FDA UDI	Class II	Active
Flexible Partial Resin	70-1164-RSN0010	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0025	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0630	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0350	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0135	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0034	FDA UDI	Class II	Active
Inclusive	70-1047-COM0151	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0203	FDA UDI	Class II	Active
Inclusive	70-1048-COM0206	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0047	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0694	FDA UDI	Class II	Active
Inclusive	70-1054-COM0166	FDA UDI	Class I	Active
BruxZir	70-1138-BSA-0954	FDA UDI	Class II	Unknown
Obsidian	70-1122-OMB0001	FDA UDI	Class II	Active
Inclusive	70-1054-COM0065	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0022	FDA UDI	Class I	Active
Inclusive	70-1176-COM0242	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0008	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0037	FDA UDI	Class II	Active
Inclusive	70-1069-IMP0009	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.