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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 98 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1135-CAM0032	FDA UDI	Class II	Active
Hahn	70-1153-PRA0075	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0231	FDA UDI	Class II	Active
Hahn	70-1153-PRC0013	FDA UDI	Class I	Active
Inclusive	70-1070-IMP0018	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0127	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0406	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0183	FDA UDI	Class II	Active
Inclusive	70-1051-COM0144	FDA UDI	Class I	Active
Inclusive	70-1053-COM0016	FDA UDI	Class I	Active
Inclusive®	70-1052-COM0161	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0283	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0082	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0514	FDA UDI	Class II	Active
Inclusive	70-1052-COM0042	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0251	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0332	FDA UDI	Class II	Unknown
BruxZir	70-1185-BXP0579	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0229	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0148	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0126	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0287	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0062	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0160	FDA UDI	Class II	Active
Inclusive	70-1052-COM0121	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0005	FDA UDI	Class II	Active
Inclusive	70-1050-COM0141	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0718	FDA UDI	Class II	Unknown
Inclusive	70-1049-COM0067	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0125	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0013	FDA UDI	Class II	Unknown
Inclusive®	70-1190-COM0103	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0042	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0054	FDA UDI	Class I	Active
Inclusive®	70-1194-COM0008	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0551	FDA UDI	Class II	Active
Inclusive	70-1139-COM0035	FDA UDI	Class I	Active
Inclusive	70-1049-COM0044	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0129	FDA UDI	Class II	Active
Inclusive	70-1176-COM0317	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0018	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0366	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0104	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0023	FDA UDI	Class II	Active
Inclusive	70-1176-COM0216	FDA UDI	Class I	Unknown
Hahn	70-1153-PRC0005	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0048	FDA UDI	Class II	Active
Inclusive	70-1051-COM0235	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0017	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0227	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.