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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 14 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1073-PRA0091	FDA UDI	Class I	Active
BruxZir	70-1157-BXA0010	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0139	FDA UDI	Class II	Active
Inclusive	70-1051-COM0280	FDA UDI	Class II	Active
Inclusive	70-1176-COM0226	FDA UDI	Class II	Active
Hahn	70-1153-PRC0031	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0041	FDA UDI	Class I	Unknown
EndSnorZ Sleep Appliance	ENDSNZL	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0218	FDA UDI	Class II	Unknown
Inclusive	70-1049-COM0058	FDA UDI	Class II	Active
Inclusive	70-1176-COM0295	FDA UDI	Class I	Active
BruxZir Spray Glaze Powder	70-1042-CER0001	FDA UDI	Class II	Active
Inclusive®	70-1169-COM0013	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0416	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0011	FDA UDI	Class II	Active
Inclusive	70-1050-COM0083	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0019	FDA UDI	Class II	Unknown
Inclusive	70-1054-COM0011	FDA UDI	Class I	Active
BruxZir	70-1158-BXA0011	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0067	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0051	FDA UDI	Class II	Active
Inclusive	70-1054-COM0071	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0280	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0048	FDA UDI	Class I	Active
Inclusive	70-1048-COM0126	FDA UDI	Class I	Unknown
BruxZir®	70-1185-NOW0024	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0147	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0013	FDA UDI	Class II	Active
Inclusive	70-1055-COM0033	FDA UDI	Class I	Unknown
Inclusive	70-1052-COM0091	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0015	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0020	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0265	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0587	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0072	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0934	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0066	FDA UDI	Class II	Active
Inclusive	70-1051-COM0091	FDA UDI	Class II	Active
Hahn	70-1153-PRS0003	FDA UDI	Class II	Active
Inclusive	70-1069-IMP0013	FDA UDI	Class II	Active
BruxZir NOW	70-1184-NOW0006	FDA UDI	Class II	Active
Inclusive	70-1048-COM0212	FDA UDI	Class I	Active
BruxZir	70-1159-BXA0004	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0129	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0069	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0106	FDA UDI	Class II	Active
Inclusive	70-1051-COM0093	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0286	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0104	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0006	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.