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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 109 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1147-COM0032	FDA UDI	Class II	Active
Inclusive	70-1050-COM0072	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0074	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0081	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0555	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0073	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0150	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0276	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0025	FDA UDI	Class I	Active
Inclusive	70-1176-COM0330	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0013	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0147	FDA UDI	Class II	Active
Inclusive	70-1052-COM0071	FDA UDI	Class I	Active
Glidewell IH™	70-1074-PRS0079	FDA UDI	Class II	Active
Inclusive	70-1048-COM0157	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0215	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0134	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0353	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0399	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0286	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0063	FDA UDI	Class II	Active
Inclusive	70-1047-COM0256	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0379	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0647	FDA UDI	Class II	Unknown
BruxZir	70-1118-BXS0083	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0494	FDA UDI	Class II	Active
Inclusive	70-1139-COM0042	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0052	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0121	FDA UDI	Class II	Unknown
BruxZir	70-1119-BXS0053	FDA UDI	Class II	Unknown
Inclusive	70-1047-COM0212	FDA UDI	Class I	Active
Inclusive	70-1052-COM0087	FDA UDI	Class II	Active
Inclusive	70-1048-COM0003	FDA UDI	Class II	Active
Inclusive	70-1047-COM0155	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0727	FDA UDI	Class II	Active
Inclusive	70-1147-COM0017	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0184	FDA UDI	Class I	Active
Inclusive	70-1052-COM0076	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0584	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0021	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0092	FDA UDI	Class I	Active
Inclusive	70-1051-COM0249	FDA UDI	Class I	Active
Inclusive	70-1051-COM0185	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0138	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0532	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0451	FDA UDI	Class II	Active
Inclusive®	70-1169-COM0004	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0027	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0033	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0125	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.