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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 3 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1176-COM0396	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0059	FDA UDI	Class I	Active
Inclusive	70-1053-COM0019	FDA UDI	Class I	Active
BruxZir Esthetic NOW	70-1182-NOW0002	FDA UDI	Class II	Active
Inclusive	70-1055-COM0010	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0154	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0073	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0038	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0097	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRC0046	FDA UDI	Class I	Active
Inclusive	70-1051-COM0048	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0079	FDA UDI	Class II	Active
Inclusive	70-1051-COM0190	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0702	FDA UDI	Class II	Active
Inclusive	70-1176-COM0328	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0209	FDA UDI	Class II	Active
Inclusive	70-1052-COM0052	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0037	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0341	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0255	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0095	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0005	FDA UDI	Class II	Active
Inclusive	70-1053-COM0100	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0111	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0170	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0006	FDA UDI	Class II	Active
Inclusive	70-1052-COM0021	FDA UDI	Class II	Active
Inclusive	70-1070-IMP0036	FDA UDI	Class II	Active
Inclusive	70-1139-COM0063	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0045	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0031	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0106	FDA UDI	Class II	Unknown
BruxZir NOW	70-1167-NOW0080	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0044	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0968	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0013	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0350	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0103	FDA UDI	Class II	Active
Inclusive	70-1054-COM0089	FDA UDI	Class I	Unknown
Glidewell HT™	70-1071-SRG0340	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0110	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0037	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0089	FDA UDI	Class II	Unknown
BruxZir	70-1175-BZA0002	FDA UDI	Class II	Active
Inclusive	70-1055-COM0019	FDA UDI	Class I	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0162	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0408	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0280	FDA UDI	Class I	Active
Inclusive	70-1071-SRG0007	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0311	FDA UDI	Class I	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.