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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 1 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1048-COM0162	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0058	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0052	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0709	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0326	FDA UDI	Class I	Active
BruxZir	70-1119-BXS0047	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0023	FDA UDI	Class II	Active
Inclusive	70-1048-COM0170	FDA UDI	Class II	Active
Inclusive	70-1139-COM0016	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0026	FDA UDI	Class I	Active
BruxZir	4400193	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0105	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0006	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0068	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0122	FDA UDI	Class II	Active
Inclusive	70-1048-COM0150	FDA UDI	Class II	Active
Inclusive	70-1049-COM0022	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0032	FDA UDI	Class I	Active
Glidewell TuffSplint™ Appliance Resin	70-1164-RSN0007	FDA UDI	Class I	Active
Inclusive	70-1047-COM0210	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0053	FDA UDI	Class II	Active
Inclusive	70-1051-COM0169	FDA UDI	Class I	Active
BruxZir	70-1185-BXP0576	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0015	FDA UDI	Class II	Unknown
Hahn	70-1153-PRC0068	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0546	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0465	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0725	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0911	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0089	FDA UDI	Class II	Active
Hahn	70-1153-PRA0085	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0108	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0248	FDA UDI	Class II	Active
ACE Surgical	MUS0014	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0015	FDA UDI	Class II	Active
Hahn	70-1153-PRC0078	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0438	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0095	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0661	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0823	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0008	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0921	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0071	FDA UDI	Class I	Active
Inclusive	70-1176-COM0291	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0022	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0076	FDA UDI	Class II	Unknown
Inclusive	70-1048-COM0110	FDA UDI	Class I	Active
Inclusive	70-1173-COM0030	FDA UDI	Class II	Active
Inclusive	70-1053-COM0075	FDA UDI	Class II	Active
Inclusive®	70-1052-COM0159	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.