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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 5 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir®	70-1185-NOW0062	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0114	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0031	FDA UDI	Class I	Active
Inclusive	70-1050-COM0120	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0127	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0046	FDA UDI	Class II	Active
Inclusive	70-1176-COM0224	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0024	FDA UDI	Class II	Active
Inclusive	70-1139-COM0038	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0117	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0209	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0055	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0014	FDA UDI	Class II	Active
BruxZir™ Opaque Coloring Liquid	70-1123-BRX0004	FDA UDI	Class II	Active
Inclusive	70-1139-COM0071	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0066	FDA UDI	Class II	Active
BruxZir	70-1013-BRX0014	FDA UDI	Class II	Unknown
BruxZir	70-1117-BXS0119	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0008	FDA UDI	Class II	Active
Inclusive	70-1050-COM0151	FDA UDI	Class I	Active
BruxZir	70-1119-BXS0111	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0039	FDA UDI	Class II	Active
Hahn	70-1153-PRC0002	FDA UDI	Class II	Active
Inclusive®	70-1196-COM0001	FDA UDI	Class II	Active
Capture	70-1031-CAP0028	FDA UDI	Class II	Active
Hahn	70-1071-SRG0087	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0102	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0281	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRS0015	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0039	FDA UDI	Class I	Active
BruxZir	70-1118-BXS0111	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0178	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0135	FDA UDI	Class II	Active
ACE Surgical	20MUS	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0507	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0150	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0098	FDA UDI	Class II	Active
Hahn	70-1153-PRA0090	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0034	FDA UDI	Class I	Unknown
Glidewell IH™	70-1073-PRA0132	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0032	FDA UDI	Class I	Active
Hahn	70-1153-PRC0022	FDA UDI	Class I	Unknown
Inclusive	70-1072-PRC0014	FDA UDI	Class II	Active
Inclusive	70-1050-COM0106	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0101	FDA UDI	Class II	Active
ACE Surgical	2010452	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0060	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0331	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0014	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0547	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.