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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 106 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0965	FDA UDI	Class II	Active
Hahn	70-1153-PRA0122	FDA UDI	Class II	Active
Hahn	70-1153-PRA0041	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0083	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0036	FDA UDI	Class II	Active
Inclusive	70-1139-COM0033	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0016	FDA UDI	Class II	Active
Camouflage	70-1152-CMF0015	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0105	FDA UDI	Class II	Active
Inclusive	70-1147-COM0044	FDA UDI	Class II	Active
Inclusive	70-1139-COM0003	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0649	FDA UDI	Class II	Active
Inclusive	70-1054-COM0066	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0164	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0489	FDA UDI	Class II	Active
Inclusive	70-1173-COM0051	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0013	FDA UDI	Class II	Active
Hahn	70-1071-SRG0212	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0310	FDA UDI	Class I	Active
Obsidian	70-1124-PUS0075	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0080	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0124	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0289	FDA UDI	Class II	Active
Inclusive	70-1051-COM0194	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0186	FDA UDI	Class II	Active
Inclusive	70-1053-COM0053	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0453	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0020	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0149	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0010	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0632	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0811	FDA UDI	Class II	Active
Inclusive	70-1053-COM0039	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0196	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0013	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0824	FDA UDI	Class II	Active
Hahn	70-1153-PRA0089	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0456	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0294	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0922	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRC0018	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0287	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0167	FDA UDI	Class II	Active
Inclusive	70-1048-COM0179	FDA UDI	Class I	Active
Inclusive	70-1048-COM0098	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0019	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0222	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0916	FDA UDI	Class II	Unknown
Inclusive	70-1055-COM0017	FDA UDI	Class I	Unknown
Camouflage	70-1151-CMU0004	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.