Is this your brand? Sign in to claim ownership.

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 18 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1051-COM0114	FDA UDI	Class I	Active
Inclusive	70-1071-SRG0160	FDA UDI	Class I	Active
BruxZir	4400192	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0037	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0009	FDA UDI	Class II	Unknown
Hahn	70-1071-SRG0195	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0120	FDA UDI	Class II	Active
Inclusive	70-1047-COM0187	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0131	FDA UDI	Class II	Active
Inclusive	70-1147-COM0062	FDA UDI	Class I	Active
Inclusive	70-1048-COM0161	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0034	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0031	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0090	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0964	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0891	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0154	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0028	FDA UDI	Class I	Active
BruxZir	70-1013-BRX0012	FDA UDI	Class II	Unknown
Glidewell HT™	70-1189-IMP0017	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0007	FDA UDI	Class II	Active
Inclusive	70-1147-COM0048	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0069	FDA UDI	Class I	Active
Inclusive	70-1147-COM0065	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0004	FDA UDI	Class I	Active
Inclusive	70-1176-COM0240	FDA UDI	Class I	Active
Inclusive	70-1176-COM0402	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0028	FDA UDI	Class II	Active
Inclusive	70-1054-COM0170	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0160	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0013	FDA UDI	Class I	Active
Capture	70-1031-CAP0023	FDA UDI	Class II	Active
BruxZir	4400176	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0712	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0550	FDA UDI	Class II	Unknown
Inclusive	70-1054-COM0103	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0110	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRS0012	FDA UDI	Class II	Active
Glidewell IH™	70-1207-IMP0008	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0118	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0142	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0100	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0002	FDA UDI	Class II	Active
BruxZir	4400173	FDA UDI	Class II	Active
Inclusive	70-1139-COM0018	FDA UDI	Class I	Active
Inclusive	70-1176-COM0222	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0298	FDA UDI	Class II	Unknown
Camouflage	70-1152-CMF0007	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0110	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0234	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.