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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 99 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1051-COM0213	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0175	FDA UDI	Class II	Active
Hahn	70-1153-IMP0003	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0217	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0096	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0074	FDA UDI	Class II	Active
Inclusive	70-1047-COM0167	FDA UDI	Class I	Active
Glidewell IH™	70-1207-IMP0006	FDA UDI	Class II	Active
Hahn	70-1154-IMP0015	FDA UDI	Class II	Active
Inclusive	70-1047-COM0174	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0012	FDA UDI	Class II	Active
Inclusive	70-1050-COM0102	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0005	FDA UDI	Class II	Unknown
Inclusive®	70-1055-COM0052	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0034	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0176	FDA UDI	Class I	Active
Inclusive®	70-1194-COM0012	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0021	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0078	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0119	FDA UDI	Class II	Unknown
Inclusive	70-1053-COM0055	FDA UDI	Class I	Active
Glidewell IH™	70-1206-IMP0012	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0023	FDA UDI	Class II	Active
Hahn	70-1071-SRG0055	FDA UDI	Class I	Active
Inclusive	70-1050-COM0020	FDA UDI	Class II	Active
Capture	70-1031-CAP0026	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0100	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0120	FDA UDI	Class II	Active
ACE Surgical	305060	FDA UDI	Class II	Active
Inclusive	70-1173-COM0019	FDA UDI	Class II	Active
Inclusive	70-1047-COM0162	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0002	FDA UDI	Class II	Active
Hahn	70-1153-PRC0052	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0569	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0064	FDA UDI	Class II	Active
Inclusive	70-1139-COM0020	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0012	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0013	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0478	FDA UDI	Class II	Active
ACE Surgical	3043MUS	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0055	FDA UDI	Class II	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0027	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0917	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0025	FDA UDI	Class I	Active
Inclusive	70-1139-COM0015	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0242	FDA UDI	Class II	Active
Inclusive	70-1047-COM0253	FDA UDI	Class I	Active
Inclusive®	70-1193-COM0005	FDA UDI	Class I	Active
Inclusive	70-1050-COM0118	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0095	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.