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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 94 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0537	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0652	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0571	FDA UDI	Class II	Active
Inclusive	70-1054-COM0043	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0158	FDA UDI	Class II	Unknown
Inclusive	70-1172-COM0004	FDA UDI	Class I	Active
Inclusive	70-1176-COM0268	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0101	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0296	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0092	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0095	FDA UDI	Class II	Active
Inclusive®	70-1052-COM0154	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0009	FDA UDI	Class II	Active
Inclusive®	70-1056-COM0023	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0027	FDA UDI	Class II	Unknown
Inclusive	70-1067-MNI0004	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0720	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0097	FDA UDI	Class II	Unknown
BruxZir	70-1155-BXA0003	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0107	FDA UDI	Class II	Active
ACE Surgical	3010351	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0117	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0026	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0160	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0413	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0053	FDA UDI	Class II	Active
Inclusive	70-1048-COM0195	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0029	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0239	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0145	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0130	FDA UDI	Class II	Active
Inclusive	70-1052-COM0102	FDA UDI	Class I	Active
Inclusive	70-1050-COM0080	FDA UDI	Class II	Active
Inclusive®	70-1169-COM0005	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0006	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0104	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0120	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0115	FDA UDI	Class II	Unknown
Inclusive	70-1147-COM0049	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0012	FDA UDI	Class I	Active
BruxZir	4400188	FDA UDI	Class II	Active
Inclusive	70-1049-COM0051	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0018	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0005	FDA UDI	Class II	Active
Inclusive	70-1048-COM0122	FDA UDI	Class II	Active
Inclusive	70-1047-COM0145	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0015	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0245	FDA UDI	Class II	Active
Inclusive	70-1047-COM0132	FDA UDI	Class I	Active
Inclusive	70-1054-COM0163	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.