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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 16 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1135-CAM0146	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0014	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0133	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0052	FDA UDI	Class I	Active
Hahn	70-1153-PRA0039	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0930	FDA UDI	Class II	Active
Glidewell™ 3DP Denture Teeth Resin	70-1164-GBD0015	FDA UDI	Class II	Active
Hahn	70-1153-PRA0086	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0426	FDA UDI	Class II	Active
Inclusive	70-1051-COM0171	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0119	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0012	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0504	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0423	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0261	FDA UDI	Class II	Active
Hahn	70-1153-PRA0084	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0180	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0107	FDA UDI	Class II	Unknown
Inclusive®	70-1192-COM0037	FDA UDI	Class I	Active
Glidewell HT™	70-1189-IMP0003	FDA UDI	Class II	Active
Inclusive®	70-1196-COM0003	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0072	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0017	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0077	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0222	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0014	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0893	FDA UDI	Class II	Unknown
Camouflage	70-1151-CMU0028	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0353	FDA UDI	Class I	Active
Glidewell IH™	70-1206-IMP0006	FDA UDI	Class II	Active
BruxZir	70-1175-BZA0008	FDA UDI	Class II	Active
Inclusive	70-1050-COM0054	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0028	FDA UDI	Class I	Active
Camouflage	70-1151-CMU0042	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0039	FDA UDI	Class I	Active
Hahn	70-1153-IMP0009	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0048	FDA UDI	Class II	Active
Inclusive	70-1051-COM0105	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0447	FDA UDI	Class I	Active
Inclusive	70-1147-COM0071	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0043	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0031	FDA UDI	Class II	Active
Hahn	70-1071-SRG0215	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0102	FDA UDI	Class II	Active
Inclusive	70-1048-COM0085	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0278	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0030	FDA UDI	Class II	Active
Hahn	70-1153-PRA0017	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0010	FDA UDI	Class II	Active
Hahn	70-1153-PRC0024	FDA UDI	Class I	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.