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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 90 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0394	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0024	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0905	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0155	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0038	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0351	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0148	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0442	FDA UDI	Class II	Active
Inclusive	70-1053-COM0023	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0253	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0415	FDA UDI	Class II	Active
Hahn	70-1153-PRC0015	FDA UDI	Class I	Active
Inclusive	70-1054-COM0010	FDA UDI	Class I	Active
Inclusive	70-1054-COM0002	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0004	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0402	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0007	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0500	FDA UDI	Class II	Active
Hahn	70-1153-IMP0008	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0368	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0047	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0226	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0106	FDA UDI	Class II	Active
Inclusive	70-1052-COM0089	FDA UDI	Class II	Active
Hahn	70-1071-SRG0057	FDA UDI	Class I	Active
Inclusive	70-1050-COM0022	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0099	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0002	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0547	FDA UDI	Class II	Active
Inclusive	70-1053-COM0083	FDA UDI	Class II	Active
Inclusive	70-1153-PRA0101	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0174	FDA UDI	Class I	Unknown
Inclusive	70-1047-COM0181	FDA UDI	Class I	Unknown
Inclusive®	70-1192-COM0007	FDA UDI	Class II	Active
Inclusive	70-1173-COM0029	FDA UDI	Class II	Active
Inclusive	70-1048-COM0205	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0101	FDA UDI	Class II	Unknown
BruxZir®	70-1185-NOW0130	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0159	FDA UDI	Class II	Active
Inclusive	70-1173-COM0026	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0120	FDA UDI	Class II	Active
Hahn	70-1153-PRS0002	FDA UDI	Class II	Active
Inclusive	70-1052-COM0043	FDA UDI	Class II	Active
BruxZir NOW	70-1182-NOW0019	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0161	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0206	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0049	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0075	FDA UDI	Class II	Active
Glidewell™ 3DP Denture Teeth Resin	70-1164-GBD0013	FDA UDI	Class II	Active
Inclusive	70-1147-COM0056	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.