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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 9 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0939	FDA UDI	Class II	Active
Inclusive	70-1054-COM0087	FDA UDI	Class I	Active
Inclusive	70-1176-COM0294	FDA UDI	Class I	Active
Inclusive	70-1051-COM0209	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0408	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0154	FDA UDI	Class II	Unknown
Inclusive®	70-1172-COM0032	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0128	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0067	FDA UDI	Class II	Unknown
Hahn	70-1071-SRG0223	FDA UDI	Class I	Active
Hahn	70-1071-SRG0061	FDA UDI	Class I	Active
BruxZir	4400191	FDA UDI	Class II	Active
Inclusive	70-1051-COM0146	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0189	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0543	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0086	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0192	FDA UDI	Class II	Active
Inclusive	70-1052-COM0145	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0174	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0025	FDA UDI	Class I	Active
Inclusive	70-1051-COM0062	FDA UDI	Class II	Active
Inclusive	70-1153-PRA0028	FDA UDI	Class I	Unknown
Inclusive®	70-1190-COM0108	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0021	FDA UDI	Class II	Active
Inclusive	70-1147-COM0012	FDA UDI	Class I	Active
Inclusive	70-1052-COM0148	FDA UDI	Class II	Active
Inclusive	70-1054-COM0106	FDA UDI	Class I	Active
Hahn	70-1153-PRC0032	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0356	FDA UDI	Class II	Unknown
Hahn	70-1153-PRS0006	FDA UDI	Class II	Active
Hahn	70-1071-SRG0179	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0106	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0061	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0064	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0033	FDA UDI	Class II	Unknown
Inclusive	70-1153-PRA0033	FDA UDI	Class I	Unknown
Inclusive	70-1069-IMP0002	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0001	FDA UDI	Class II	Active
Hahn	70-1153-PRC0067	FDA UDI	Class I	Active
Silent Nite Sleep Appliance with Glidewell Hinge	SNGLHGXPHL	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0021	FDA UDI	Class I	Active
BruxZir	70-1156-BXA0014	FDA UDI	Class II	Active
Inclusive	70-1051-COM0217	FDA UDI	Class I	Active
Inclusive	70-1067-MNI0002	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0024	FDA UDI	Class II	Active
Inclusive	70-1051-COM0145	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0257	FDA UDI	Class II	Active
Hahn	70-1153-PRC0050	FDA UDI	Class I	Active
Inclusive	70-1047-COM0182	FDA UDI	Class I	Unknown
Camouflage	70-1151-CMU0024	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.