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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 6 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive®	70-1190-COM0020	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRS0019	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0176	FDA UDI	Class II	Active
Inclusive	70-1053-COM0043	FDA UDI	Class I	Unknown
BruxZir	70-1157-BXA0016	FDA UDI	Class II	Active
Hahn	70-1153-PRC0046	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0010	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0170	FDA UDI	Class II	Active
Inclusive	70-1069-IMP0001	FDA UDI	Class II	Active
Inclusive	70-1051-COM0086	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0010	FDA UDI	Class I	Active
Inclusive	70-1176-COM0197	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0156	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0063	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0017	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0058	FDA UDI	Class I	Active
BruxZir	70-1118-BXS0113	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0145	FDA UDI	Class II	Active
Inclusive	70-1052-COM0144	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0125	FDA UDI	Class I	Active
ACE Surgical	2073560	FDA UDI	Class II	Active
Inclusive	70-1050-COM0124	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0032	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0094	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0295	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0172	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0063	FDA UDI	Class II	Active
Inclusive	70-1050-COM0030	FDA UDI	Class II	Active
Inclusive	70-1048-COM0004	FDA UDI	Class II	Active
Inclusive	70-1048-COM0199	FDA UDI	Class I	Active
Hahn	70-1153-PRC0027	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0118	FDA UDI	Class II	Active
Inclusive	70-1173-COM0013	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0073	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0193	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0151	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0017	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0065	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0132	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0017	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0146	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0163	FDA UDI	Class II	Active
Inclusive	70-1173-COM0010	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0002	FDA UDI	Class II	Unknown
Inclusive®	70-1192-COM0039	FDA UDI	Class I	Active
Inclusive	70-1176-COM0271	FDA UDI	Class I	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0034	FDA UDI	Class II	Active
Inclusive®	70-1169-COM0003	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0296	FDA UDI	Class I	Active
Inclusive	70-1139-COM0019	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.