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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 12 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1047-COM0176	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0038	FDA UDI	Class I	Active
Inclusive	70-1049-COM0077	FDA UDI	Class II	Active
Inclusive	70-1139-COM0068	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0224	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0112	FDA UDI	Class II	Unknown
BruxZir	70-1117-BXS0079	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0090	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0061	FDA UDI	Class II	Unknown
Inclusive®	70-1194-COM0032	FDA UDI	Class I	Active
Hahn	70-1071-SRG0072	FDA UDI	Class I	Active
BruxZir	1014-BRX0017	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0332	FDA UDI	Class I	Active
BruxZir	70-1157-BXA0028	FDA UDI	Class II	Active
Inclusive	70-1071-IMP0002	FDA UDI	Class I	Active
CAMouflage	70-1000-CMN0019	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0095	FDA UDI	Class II	Unknown
Hahn	70-1153-PRA0003	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0078	FDA UDI	Class II	Active
Inclusive	70-1147-COM0063	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0008	FDA UDI	Class II	Active
Inclusive	70-1049-COM0024	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0032	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0579	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0586	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0491	FDA UDI	Class II	Active
Inclusive	70-1054-COM0044	FDA UDI	Class II	Active
Inclusive	70-1176-COM0235	FDA UDI	Class I	Active
BruxZir	70-1157-BXA0011	FDA UDI	Class II	Active
Hahn	70-1153-PRA0083	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0061	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0011	FDA UDI	Class II	Active
Hahn	70-1153-PRA0009	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0363	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0259	FDA UDI	Class II	Active
Inclusive	70-1050-COM0117	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0004	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0051	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0097	FDA UDI	Class I	Active
BruxZir	70-1015-BRX0015	FDA UDI	Class II	Active
ACE Surgical	3043MU17	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0127	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0028	FDA UDI	Class II	Active
Inclusive	70-1050-COM0053	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0003	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0027	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0018	FDA UDI	Class I	Active
BruxZir	70-1157-BXA0009	FDA UDI	Class II	Unknown
Inclusive	70-1173-COM0034	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0955	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.