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 17 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir®	70-1185-NOW0128	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0116	FDA UDI	Class II	Unknown
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0023	FDA UDI	Class II	Active
Inclusive	70-1050-COM0021	FDA UDI	Class II	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0029	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0052	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0051	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0266	FDA UDI	Class I	Active
Inclusive®	70-1055-COM0057	FDA UDI	Class II	Active
Inclusive	70-1066-MNP0003	FDA UDI	Class I	Unknown
Inclusive®	70-1071-SRG0381	FDA UDI	Class I	Active
BruxZir®	70-1182-NOW0075	FDA UDI	Class II	Active
Inclusive	70-1047-COM0139	FDA UDI	Class II	Active
Glidewell IH™	70-1206-IMP0027	FDA UDI	Class II	Active
Inclusive	70-1048-COM0140	FDA UDI	Class II	Active
BruxZir	70-1013-BRX0011	FDA UDI	Class II	Unknown
BruxZir	70-25AM	FDA UDI	Class I	Active
Inclusive	70-1053-COM0064	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0464	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0398	FDA UDI	Class II	Active
Inclusive	70-1048-COM0016	FDA UDI	Class I	Active
BruxZir	70-1010-BRX0178	FDA UDI	Class II	Active
Obsidian®	70-1200-OBN0006	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0047	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0307	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0949	FDA UDI	Class II	Active
Inclusive	70-1054-COM0178	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0910	FDA UDI	Class II	Active
Hahn	70-1071-SRG0054	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0341	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0111	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0011	FDA UDI	Class II	Active
Inclusive	70-1047-COM0029	FDA UDI	Class II	Active
Inclusive	70-1176-COM0249	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0065	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRS0011	FDA UDI	Class II	Active
Inclusive	70-1051-COM0229	FDA UDI	Class I	Unknown
Inclusive	70-1051-COM0148	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0137	FDA UDI	Class II	Unknown
Inclusive®	70-1194-COM0027	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0154	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0269	FDA UDI	Class I	Active
Inclusive	70-1052-COM0110	FDA UDI	Class I	Unknown
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0041	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0080	FDA UDI	Class II	Active
Inclusive	70-1047-COM0079	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0004	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0134	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0697	FDA UDI	Class II	Unknown
Inclusive	70-1153-PRA0032	FDA UDI	Class I	Unknown

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.