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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 19 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Esthetic	70-1183-BEP0114	FDA UDI	Class II	Active
Inclusive	70-1176-COM0229	FDA UDI	Class II	Active
Hahn	70-1154-IMP0009	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0118	FDA UDI	Class II	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0026	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0012	FDA UDI	Class II	Active
Inclusive	70-1139-COM0053	FDA UDI	Class II	Active
Inclusive	70-1047-COM0004	FDA UDI	Class II	Active
Hahn	70-1153-PRA0064	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0025	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0187	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0092	FDA UDI	Class II	Unknown
BruxZir®	70-1185-NOW0081	FDA UDI	Class II	Active
Hahn	70-1071-SRG0171	FDA UDI	Class I	Active
Hahn	70-1153-PRA0081	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0027	FDA UDI	Class II	Unknown
Inclusive®	70-1071-SRG0386	FDA UDI	Class I	Active
Camouflage	70-1152-CMF0006	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0201	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0109	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0131	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0119	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0038	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0010	FDA UDI	Class II	Active
Hahn	70-1153-PRC0075	FDA UDI	Class I	Active
BruxZir	70-1013-BRX0006	FDA UDI	Class II	Unknown
Camouflage	70-1151-CMU0033	FDA UDI	Class II	Active
BruxZir	70-1175-BZA0012	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0061	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0114	FDA UDI	Class II	Active
Hahn	70-1071-SRG0169	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0032	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0033	FDA UDI	Class II	Active
Inclusive	70-1047-COM0204	FDA UDI	Class II	Active
Inclusive®	70-1196-COM0002	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0122	FDA UDI	Class II	Unknown
Inclusive	70-1047-COM0005	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0104	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0023	FDA UDI	Class I	Active
BruxZir	70-1157-BXA0006	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0617	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0090	FDA UDI	Class II	Unknown
BruxZir	70-1010-BRX0179	FDA UDI	Class II	Active
ACE Surgical	2035MUA	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0039	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0105	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0436	FDA UDI	Class II	Active
Hahn	70-1153-IMP0002	FDA UDI	Class II	Active
Inclusive	70-1172-COM0003	FDA UDI	Class I	Active
BruxZir	70-1155-BXA0023	FDA UDI	Class II	Unknown

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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.