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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 97 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1053-COM0109	FDA UDI	Class I	Active
Inclusive	70-1053-COM0028	FDA UDI	Class I	Active
Inclusive	70-1173-COM0012	FDA UDI	Class II	Active
Inclusive	70-1051-COM0279	FDA UDI	Class II	Active
Inclusive®	70-1170-COM0020	FDA UDI	Class I	Active
Inclusive	70-1174-SRG0009	FDA UDI	Class I	Active
Glidewell™	70-1071-PRS0004	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0074	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0126	FDA UDI	Class II	Unknown
Inclusive	70-1068-IMP0005	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0028	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0812	FDA UDI	Class II	Active
Glidewell™	70-1204-WPS0001	FDA UDI	Class II	Active
BruxZir	70-1014-BRX0019	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0046	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0023	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRA0018	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0054	FDA UDI	Class II	Active
Hahn	70-1153-PRC0044	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0135	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0250	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0137	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0072	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0103	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0022	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0039	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0022	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0001	FDA UDI	Class II	Unknown
BruxZir	70-1159-BXA0012	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0022	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0564	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0158	FDA UDI	Class II	Unknown
Glidewell IH™	70-1072-PRC0070	FDA UDI	Class I	Active
Glidewell™ 3DP Denture Teeth Resin	70-1164-GBD0008	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0259	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0095	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0061	FDA UDI	Class I	Active
Hahn	70-1153-PRC0049	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0708	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0092	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0024	FDA UDI	Class I	Active
Hahn	70-1153-PRS0008	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0055	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0198	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0013	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0264	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0011	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0068	FDA UDI	Class II	Active
Hahn	70-1153-PRA0093	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0019	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.