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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 102 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1176-COM0248	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0070	FDA UDI	Class I	Active
BruxZir	70-1156-BXA0020	FDA UDI	Class II	Active
Hahn	70-1153-PRA0034	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0011	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0028	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0029	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0013	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0038	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRS0005	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0036	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0003	FDA UDI	Class II	Active
Inclusive	70-1176-COM0301	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0306	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0145	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0003	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0018	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0120	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0086	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0013	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0129	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0089	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0290	FDA UDI	Class II	Active
Inclusive	70-1176-COM0208	FDA UDI	Class I	Active
Inclusive®	70-1055-COM0076	FDA UDI	Class I	Active
Inclusive	70-1051-COM0180	FDA UDI	Class II	Active
Hahn	70-1071-SRG0088	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0284	FDA UDI	Class I	Active
Inclusive	70-1049-COM0064	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0513	FDA UDI	Class II	Active
Hahn	70-1174-SRG0019	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0039	FDA UDI	Class I	Active
Inclusive	70-1047-COM0119	FDA UDI	Class I	Active
Inclusive	70-1139-COM0062	FDA UDI	Class I	Active
Inclusive	70-1176-COM0332	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0102	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRS0004	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0035	FDA UDI	Class I	Active
Obsidian	70-1122-OMB0057	FDA UDI	Class II	Active
Inclusive	70-1053-COM0025	FDA UDI	Class I	Active
BruxZir	70-1118-BXS0071	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0001	FDA UDI	Class I	Active
BruxZir	70-1119-BXS0029	FDA UDI	Class II	Active
Inclusive	70-1066-MNP0006	FDA UDI	Class I	Active
Glidewell™ 3DP Denture Base Resin - Shade G1	70-1164-GBD0001	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0014	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0012	FDA UDI	Class II	Active
Inclusive	70-1050-COM0148	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0347	FDA UDI	Class I	Active
Inclusive	70-1050-COM0084	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.