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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 107 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive®	70-1190-COM0014	FDA UDI	Class II	Active
Obsidian®	70-1200-OBN0001	FDA UDI	Class II	Active
Inclusive	70-1053-COM0017	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0026	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0112	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0084	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0074	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0380	FDA UDI	Class II	Unknown
BruxZir®	70-1182-NOW0078	FDA UDI	Class II	Active
Inclusive	70-1176-COM0290	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0957	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0522	FDA UDI	Class II	Active
Inclusive	70-1047-COM0086	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0701	FDA UDI	Class II	Unknown
Hahn	70-1153-PRC0017	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0108	FDA UDI	Class II	Active
Hahn	70-1153-PRA0091	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0029	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0017	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0090	FDA UDI	Class II	Active
ACE Surgical	30435060S	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0035	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0049	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0074	FDA UDI	Class II	Active
Inclusive	70-1176-COM0385	FDA UDI	Class I	Active
Inclusive	70-1176-COM0404	FDA UDI	Class I	Active
Inclusive	70-1176-COM0323	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0023	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0015	FDA UDI	Class II	Active
Inclusive	70-1050-COM0061	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0365	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0577	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0233	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0275	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0675	FDA UDI	Class II	Unknown
Inclusive	70-1147-COM0093	FDA UDI	Class I	Active
Hahn	70-1153-PRC0030	FDA UDI	Class I	Active
Inclusive®	70-1178-COM0003	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0029	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0130	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0015	FDA UDI	Class I	Active
Glidewell IH™	70-1206-IMP0008	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0044	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0021	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0007	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0018	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0186	FDA UDI	Class II	Active
Inclusive	70-1147-COM0043	FDA UDI	Class II	Active
Inclusive	70-1070-IMP0005	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0004	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.