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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 91 of 112

Device	Model / Reference	Registries	Class	Status
ACE Surgical	30353	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0426	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0590	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0012	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0281	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0230	FDA UDI	Class II	Active
Inclusive	70-1147-COM0047	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0049	FDA UDI	Class I	Active
Inclusive	70-1050-COM0010	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0185	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0556	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0155	FDA UDI	Class II	Active
Capture	70-1031-CAP0024	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0039	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0057	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0220	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0256	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0039	FDA UDI	Class I	Active
BruxZir	70-1010-BRX0183	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0118	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0066	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0122	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0039	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0017	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0272	FDA UDI	Class II	Active
Inclusive	70-1054-COM0176	FDA UDI	Class I	Active
Inclusive	70-1052-COM0098	FDA UDI	Class I	Active
BruxZir	70-1158-BXA0026	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0304	FDA UDI	Class II	Unknown
Glidewell™ 3DP Denture Teeth Resin Shade A1	70-1164-GBD0004	FDA UDI	Class II	Active
Hahn	70-1153-PRA0035	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0126	FDA UDI	Class I	Active
Inclusive	70-1173-COM0007	FDA UDI	Class I	Unknown
Silent Nite Sleep Appliance with Glidewell Hinge	SNGLHG	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0013	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0016	FDA UDI	Class I	Active
BruxZir	70-1014-BRX0018	FDA UDI	Class I	Active
Inclusive	70-1047-COM0089	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0225	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0032	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0102	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0002	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0083	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0006	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0081	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0089	FDA UDI	Class I	Active
Inclusive	70-1074-PRS0059	FDA UDI	Class I	Active
BruxZir	70-1118-BXS0023	FDA UDI	Class II	Unknown
Inclusive	70-1147-COM0055	FDA UDI	Class II	Active
Inclusive	70-1048-COM0154	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.