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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 103 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1158-BXA0008	FDA UDI	Class II	Active
Inclusive	70-1047-COM0096	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0379	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0298	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0159	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0003	FDA UDI	Class II	Active
Camouflage	70-1152-CMF0008	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0025	FDA UDI	Class II	Unknown
Inclusive	70-1048-COM0175	FDA UDI	Class I	Active
Inclusive	70-1048-COM0167	FDA UDI	Class I	Active
Inclusive	70-1173-COM0022	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0484	FDA UDI	Class II	Active
BruxZir	4400432	FDA UDI	Class II	Active
Inclusive	70-1052-COM0122	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0674	FDA UDI	Class II	Active
Inclusive	70-1047-COM0090	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0033	FDA UDI	Class II	Active
Inclusive®	70-1193-COM0007	FDA UDI	Class I	Active
BruxZir	70-1117-BXS0107	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0117	FDA UDI	Class II	Unknown
Inclusive	70-1069-IMP0008	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0037	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0044	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0334	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0415	FDA UDI	Class I	Active
Inclusive	70-1074-PRS0021	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0048	FDA UDI	Class I	Active
BruxZir	70-1175-BZA0003	FDA UDI	Class II	Unknown
Hahn	70-1153-PRA0123	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0093	FDA UDI	Class II	Active
fastscan.io	70-1181-MIL0153	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0073	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0011	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0028	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0070	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0019	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0038	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0125	FDA UDI	Class II	Active
Inclusive	70-1051-COM0234	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0023	FDA UDI	Class I	Active
Inclusive	70-1049-COM0056	FDA UDI	Class II	Active
Inclusive	70-1067-MNI0003	FDA UDI	Class I	Active
Inclusive	70-1139-COM0064	FDA UDI	Class I	Active
Glidewell IH™	70-1074-PRS0096	FDA UDI	Class I	Active
Inclusive	70-1048-COM0093	FDA UDI	Class II	Active
Inclusive	70-1139-COM0037	FDA UDI	Class I	Active
Inclusive	70-1147-COM0092	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0510	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0210	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0002	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.