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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 4 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1010-BRX0044	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0110	FDA UDI	Class II	Active
Inclusive	70-1048-COM0101	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0359	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0525	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0049	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0284	FDA UDI	Class II	Active
Hahn	70-1153-PRA0074	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0024	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0003	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0095	FDA UDI	Class II	Active
Inclusive	70-1176-COM0201	FDA UDI	Class II	Active
Inclusive	70-1153-PRA0100	FDA UDI	Class II	Active
Inclusive	70-1049-COM0016	FDA UDI	Class II	Active
Glidewell IH™	70-1206-IMP0021	FDA UDI	Class II	Active
Inclusive	70-1173-COM0028	FDA UDI	Class II	Active
Inclusive	70-1139-COM0014	FDA UDI	Class II	Active
Inclusive	70-1147-COM0016	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0055	FDA UDI	Class I	Active
Hahn	70-1071-SRG0213	FDA UDI	Class I	Active
Inclusive	70-1048-COM0006	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0054	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0001	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0477	FDA UDI	Class II	Active
Inclusive®	70-1056-COM0041	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0923	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0105	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0346	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0056	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0064	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0515	FDA UDI	Class II	Active
Inclusive	70-1051-COM0269	FDA UDI	Class I	Active
Inclusive	70-1052-COM0077	FDA UDI	Class II	Active
Inclusive	70-1053-COM0108	FDA UDI	Class I	Active
Silent Nite 3D Sleep Appliance	MA-PC-SD-OP	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0549	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0337	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0206	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0463	FDA UDI	Class II	Active
Hahn	70-1153-PRC0073	FDA UDI	Class I	Active
BruxZir	70-1013-BRX0007	FDA UDI	Class II	Unknown
BruxZir	70-1014-BRX0012	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0047	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0105	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0073	FDA UDI	Class I	Active
BruxZir	70-1013-BRX0004	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0172	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0133	FDA UDI	Class II	Unknown
BruxZir	70-1119-BXS0096	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0020	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.