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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 93 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir®	70-1184-RAD0022	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0085	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0119	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0002	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0002	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRS0008	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0089	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0052	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0586	FDA UDI	Class II	Active
Inclusive	70-1069-IMP0003	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0064	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0067	FDA UDI	Class I	Active
Glidewell IH™	70-1071-SRG0431	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0361	FDA UDI	Class II	Unknown
Inclusive	70-1068-IMP0009	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0503	FDA UDI	Class II	Active
BruxZir	4400190	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0029	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0152	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0482	FDA UDI	Class II	Active
Inclusive	70-1139-COM0049	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0023	FDA UDI	Class II	Active
Inclusive	70-1176-COM0405	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0024	FDA UDI	Class II	Active
Inclusive	70-1147-COM0094	FDA UDI	Class I	Active
Hahn	70-1153-IMP0006	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0012	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0020	FDA UDI	Class I	Active
BruxZir	70-1186-BXP0310	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0178	FDA UDI	Class I	Active
Inclusive	70-1071-SRG0005	FDA UDI	Class I	Active
Inclusive	70-1048-COM0001	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0068	FDA UDI	Class I	Active
BruxZir	70-1158-BXA0014	FDA UDI	Class II	Active
Glidewell Zirconia Primer	70-1198-PVC0004	FDA UDI	Class II	Active
Inclusive	70-1047-COM0143	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0519	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0059	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0695	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0031	FDA UDI	Class II	Active
BruxZir	70-1175-BZA0010	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0010	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0072	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0719	FDA UDI	Class II	Active
BruxZir NOW	70-1184-NOW0002	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0538	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0300	FDA UDI	Class I	Active
Inclusive	70-1053-COM0049	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0184	FDA UDI	Class II	Active
Inclusive	70-1176-COM0269	FDA UDI	Class I	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.