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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 105 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Shaded 16 PLUS	70-1185-BXP0139	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0018	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0363	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0282	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0091	FDA UDI	Class II	Active
Hahn	70-1071-SRG0182	FDA UDI	Class I	Active
Inclusive	70-1051-COM0100	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0010	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0223	FDA UDI	Class II	Active
Inclusive	70-1050-COM0078	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0165	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0506	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0263	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0182	FDA UDI	Class II	Active
Hahn	70-1153-PRS0011	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0024	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0373	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0292	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0100	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0714	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0641	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0054	FDA UDI	Class II	Unknown
Inclusive	70-1071-PRS0001	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0039	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0098	FDA UDI	Class II	Active
Hahn	70-1153-PRC0071	FDA UDI	Class I	Active
ACE Surgical	3010352	FDA UDI	Class I	Active
Inclusive	70-1048-COM0146	FDA UDI	Class II	Active
Inclusive	70-1048-COM0065	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0309	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0254	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0001	FDA UDI	Class II	Unknown
Inclusive	70-1048-COM0180	FDA UDI	Class I	Active
Hahn	70-1071-SRG0164	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0124	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0101	FDA UDI	Class II	Unknown
BruxZir	4400196	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0170	FDA UDI	Class II	Active
BruxZir	70-1175-BZA0005	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0110	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0023	FDA UDI	Class I	Active
Hahn	70-1071-SRG0069	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0009	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0329	FDA UDI	Class I	Active
Hahn	70-1071-SRG0167	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0006	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0064	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0092	FDA UDI	Class II	Unknown
Inclusive	70-1176-COM0243	FDA UDI	Class I	Active
Camouflage	70-1151-CMU0019	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.