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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 108 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Shaded 16 PLUS	70-1185-BXP0012	FDA UDI	Class II	Active
Inclusive	70-1048-COM0159	FDA UDI	Class II	Active
Inclusive	70-1049-COM0075	FDA UDI	Class I	Active
Glidewell IH™	70-1074-PRS0081	FDA UDI	Class II	Active
Inclusive	70-1139-COM0005	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0070	FDA UDI	Class II	Active
Inclusive	70-1048-COM0132	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0335	FDA UDI	Class I	Active
Hahn	70-1071-SRG0173	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0488	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0300	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0043	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0001	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0037	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0032	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0099	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0559	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0008	FDA UDI	Class II	Active
Inclusive	70-1139-COM0043	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0015	FDA UDI	Class I	Active
Inclusive	70-1048-COM0169	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0583	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0428	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0016	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0036	FDA UDI	Class I	Active
Inclusive	70-1048-COM0116	FDA UDI	Class I	Active
BruxZir	70-1117-BXS0108	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0053	FDA UDI	Class II	Active
Inclusive	70-1053-COM0059	FDA UDI	Class II	Active
Inclusive	70-1070-IMP0016	FDA UDI	Class II	Active
Inclusive	70-1048-COM0153	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0188	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0008	FDA UDI	Class II	Unknown
Inclusive®	70-1178-COM0002	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0173	FDA UDI	Class II	Active
Inclusive	70-1053-COM0009	FDA UDI	Class II	Active
Hahn	70-1071-SRG0178	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0041	FDA UDI	Class II	Active
ACE Surgical	307435	FDA UDI	Class I	Active
Inclusive	70-1050-COM0144	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0277	FDA UDI	Class I	Active
Hahn	70-1153-PRC0033	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0021	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0014	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0174	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0109	FDA UDI	Class II	Active
Glidewell RMGI Cement	70-1198-PVC0003	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0104	FDA UDI	Class II	Active
Inclusive	70-1053-COM0061	FDA UDI	Class II	Active
Newport Biologics Bone Graft Putty Mineral Collagen Composite	70-BIO-BGP20	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.