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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 7 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1048-COM0092	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0075	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0114	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0006	FDA UDI	Class II	Active
Inclusive	70-1049-COM0062	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0032	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0006	FDA UDI	Class II	Active
Hahn	70-1153-IMP0013	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0056	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0418	FDA UDI	Class II	Active
Inclusive	70-1176-COM0227	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0174	FDA UDI	Class II	Active
Inclusive	70-1050-COM0123	FDA UDI	Class II	Active
Hahn	70-1071-SRG0192	FDA UDI	Class I	Active
Inclusive®	70-1168-COM0017	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0012	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0222	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0013	FDA UDI	Class II	Active
ACE Surgical	MU0017	FDA UDI	Class I	Active
BruxZir	70-1138-BSA-0945	FDA UDI	Class II	Unknown
Inclusive®	70-1168-COM0021	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0055	FDA UDI	Class II	Active
Inclusive	70-1054-COM0171	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0159	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0114	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0096	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0086	FDA UDI	Class II	Active
Inclusive®	70-1196-COM0006	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0058	FDA UDI	Class II	Active
Inclusive	70-1051-COM0044	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0037	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0004	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0231	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0150	FDA UDI	Class II	Active
Inclusive	70-1048-COM0202	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0898	FDA UDI	Class II	Unknown
BruxZir®	70-1185-NOW0066	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0037	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0304	FDA UDI	Class II	Active
Inclusive	70-1139-COM0060	FDA UDI	Class I	Active
Inclusive	70-1047-COM0149	FDA UDI	Class II	Active
Inclusive	70-1153-PRA0026	FDA UDI	Class I	Unknown
BruxZir®	70-1182-BZE0103	FDA UDI	Class II	Active
BruxZir	70-1014-BRX0014	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0166	FDA UDI	Class II	Active
Inclusive	70-1051-COM0233	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0124	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0141	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0589	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0271	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.