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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 100 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Esthetic	70-1183-BEP0050	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0019	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0119	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0048	FDA UDI	Class II	Active
Inclusive	70-1050-COM0071	FDA UDI	Class I	Active
Hahn	70-1071-SRG0079	FDA UDI	Class I	Active
Inclusive	70-1176-COM0314	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0166	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0055	FDA UDI	Class II	Active
Inclusive®	70-1071-SRG0383	FDA UDI	Class I	Active
Inclusive	70-1139-COM0046	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0146	FDA UDI	Class II	Unknown
Inclusive	70-1147-COM0057	FDA UDI	Class II	Active
Inclusive	70-1070-IMP0019	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0057	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0020	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0013	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0101	FDA UDI	Class II	Unknown
BruxZir™ Opaque Coloring Liquid	70-1123-BRX0003	FDA UDI	Class II	Active
Inclusive	70-1066-MNP0005	FDA UDI	Class I	Active
Hahn	70-1071-SRG0225	FDA UDI	Class I	Active
Hahn	70-1071-SRG0080	FDA UDI	Class I	Active
Inclusive	70-1176-COM0203	FDA UDI	Class II	Active
BruxZir	1014-BRX0018	FDA UDI	Class I	Active
BruxZir	70-1119-BXS0118	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0040	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0527	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0113	FDA UDI	Class II	Active
Camouflage	70-1152-CMF0018	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0479	FDA UDI	Class II	Active
Inclusive	70-1052-COM0099	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0019	FDA UDI	Class II	Active
Inclusive	70-1048-COM0114	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0029	FDA UDI	Class II	Active
Inclusive®	70-1056-COM0046	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0101	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0020	FDA UDI	Class II	Unknown
Hahn	70-1153-PRC0063	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0567	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0006	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0031	FDA UDI	Class I	Active
Inclusive	70-1147-COM0076	FDA UDI	Class II	Active
BruxZir™ Incisal Coloring Liquid	70-1123-BRX0032	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0146	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0185	FDA UDI	Class II	Active
Inclusive®	70-1071-SRG0382	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0152	FDA UDI	Class II	Active
Inclusive	70-1049-COM0057	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0056	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0082	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.