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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 21 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0278	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0188	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0117	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0036	FDA UDI	Class II	Unknown
BruxZir NOW	70-1167-NOW0091	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0572	FDA UDI	Class II	Active
Inclusive	70-1051-COM0211	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0161	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0001	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0093	FDA UDI	Class II	Active
Inclusive	70-1070-IMP0034	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0013	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0025	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0172	FDA UDI	Class I	Unknown
BruxZir®	70-1182-BZE0111	FDA UDI	Class II	Unknown
Inclusive®	70-1194-COM0001	FDA UDI	Class II	Active
Capture	70-1031-CAP0025	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0050	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0065	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0091	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0721	FDA UDI	Class II	Unknown
Inclusive®	70-1192-COM0051	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0036	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0434	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0021	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0238	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0022	FDA UDI	Class II	Active
Obsidian	4400200	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0075	FDA UDI	Class II	Active
Inclusive	70-1173-COM0042	FDA UDI	Class II	Active
Hahn	70-1153-PRA0037	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0122	FDA UDI	Class II	Active
Inclusive	70-1048-COM0088	FDA UDI	Class II	Active
Inclusive	70-1048-COM0121	FDA UDI	Class II	Active
Inclusive	70-1069-IMP0005	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0069	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0301	FDA UDI	Class I	Active
BruxZir™ Incisal Coloring Liquid	70-1123-BRX0033	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0184	FDA UDI	Class II	Active
Hahn	70-1153-PRA0061	FDA UDI	Class II	Active
Hahn	70-1153-PRC0004	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0016	FDA UDI	Class II	Active
Glidewell IH™	70-1207-IMP0014	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0128	FDA UDI	Class II	Active
Inclusive	70-1139-COM0047	FDA UDI	Class I	Active
Inclusive	70-1072-PRC0001	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0022	FDA UDI	Class II	Active
Hahn	70-1153-PRA0125	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0069	FDA UDI	Class I	Active
BruxZir	70-1175-BZA0007	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.