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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 101 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1052-COM0141	FDA UDI	Class I	Active
Inclusive	70-1147-COM0083	FDA UDI	Class I	Active
BruxZir	70-1010-BRX0189	FDA UDI	Class II	Active
Inclusive	70-1173-COM0023	FDA UDI	Class II	Active
Inclusive	70-1051-COM0098	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0156	FDA UDI	Class I	Active
Hahn	70-1071-SRG0075	FDA UDI	Class I	Active
Inclusive	70-1174-SRG0011	FDA UDI	Class I	Active
Glidewell HT™	70-1189-IMP0004	FDA UDI	Class II	Active
Inclusive	70-1051-COM0277	FDA UDI	Class II	Active
Inclusive	70-1051-COM0196	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0068	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0142	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0158	FDA UDI	Class I	Active
Inclusive	70-1054-COM0062	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0042	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0448	FDA UDI	Class II	Active
BruxZir	4400185	FDA UDI	Class II	Active
Hahn	70-1071-SRG0170	FDA UDI	Class I	Active
Inclusive	70-1054-COM0098	FDA UDI	Class I	Active
Hahn	70-1153-PRC0048	FDA UDI	Class I	Active
Glidewell IH™	70-1195-PRC0003	FDA UDI	Class I	Active
BruxZir	70-1010-BRX0190	FDA UDI	Class II	Unknown
Inclusive	70-1048-COM0125	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0005	FDA UDI	Class II	Unknown
Inclusive	70-1053-COM0022	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0684	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0002	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0657	FDA UDI	Class II	Active
Inclusive	70-1054-COM0048	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0495	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0018	FDA UDI	Class I	Active
Inclusive	70-1072-PRC0008	FDA UDI	Class I	Active
Inclusive	70-1071-SRG0015	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0035	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0238	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0135	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0942	FDA UDI	Class II	Active
Inclusive	70-1176-COM0406	FDA UDI	Class I	Active
Inclusive	70-1176-COM0325	FDA UDI	Class II	Active
Inclusive	70-1176-COM0244	FDA UDI	Class I	Active
ACE Surgical	2010351	FDA UDI	Class I	Active
Hahn	70-1153-PRA0109	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0108	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0060	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0024	FDA UDI	Class II	Unknown
Hahn	70-1153-PRA0045	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0008	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0009	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0131	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.