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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 8 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1073-PRA0002	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0100	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0085	FDA UDI	Class II	Active
Hahn	70-1071-SRG0067	FDA UDI	Class I	Active
Hahn	70-1071-SRG0229	FDA UDI	Class I	Active
Inclusive	70-1050-COM0032	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0065	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0072	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0006	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0638	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0021	FDA UDI	Class II	Unknown
Inclusive®	70-1056-COM0035	FDA UDI	Class I	Active
Inclusive	70-1153-PRA0031	FDA UDI	Class I	Unknown
Inclusive	70-1139-COM0022	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0113	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0032	FDA UDI	Class II	Active
Inclusive	70-1049-COM0040	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0110	FDA UDI	Class II	Unknown
Inclusive	70-1047-COM0215	FDA UDI	Class I	Active
Inclusive	70-1173-COM0006	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0062	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0892	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRS0007	FDA UDI	Class II	Active
Silent Nite 3D Sleep Appliance	MA-PC-SD-LA	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0017	FDA UDI	Class II	Active
Inclusive	70-1048-COM0112	FDA UDI	Class I	Active
BruxZir	70-1013-BRX0013	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRC0055	FDA UDI	Class I	Active
BruxZir	70-1119-BXS0115	FDA UDI	Class II	Active
EndSnorZ Sleep Appliance	ENDSNZU	FDA UDI	Class II	Active
Inclusive	70-1051-COM0198	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0025	FDA UDI	Class I	Active
Inclusive	70-1173-COM0040	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0065	FDA UDI	Class I	Active
Hahn	70-1153-PRS0016	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0535	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0454	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0024	FDA UDI	Class II	Active
Inclusive	70-1054-COM0105	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRS0001	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0071	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0031	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0377	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0296	FDA UDI	Class II	Unknown
Inclusive®	70-1055-COM0073	FDA UDI	Class I	Active
BruxZir	70-1118-BXS0122	FDA UDI	Class II	Active
Inclusive	70-1176-COM0283	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0106	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0063	FDA UDI	Class I	Active
Inclusive	70-1050-COM0077	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.