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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 20 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0967	FDA UDI	Class II	Active
Inclusive	70-1066-MNP0007	FDA UDI	Class I	Active
Hahn	70-1071-SRG0065	FDA UDI	Class I	Active
BioTemps	70-1181-MIL0096	FDA UDI	Class II	Active
Hahn	70-1153-PRS0005	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0013	FDA UDI	Class II	Unknown
BruxZir	70-1156-BXA0010	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0022	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0003	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0440	FDA UDI	Class I	Active
Hahn	70-1153-PRA0049	FDA UDI	Class II	Active
ACE Surgical	307505	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0200	FDA UDI	Class II	Active
Hahn	70-1153-PRA0092	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0069	FDA UDI	Class II	Active
Inclusive	70-1048-COM0115	FDA UDI	Class I	Active
Inclusive	70-1051-COM0262	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0170	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0026	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0142	FDA UDI	Class II	Active
Inclusive	70-1052-COM0123	FDA UDI	Class II	Active
Inclusive	70-1051-COM0216	FDA UDI	Class I	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0038	FDA UDI	Class II	Active
Glidewell™	70-1084-IKT0001	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0575	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0667	FDA UDI	Class II	Unknown
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0011	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0050	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0071	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0663	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0042	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0427	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0064	FDA UDI	Class I	Active
Inclusive	70-1176-COM0237	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0034	FDA UDI	Class II	Active
Inclusive	70-1176-COM0254	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0300	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0164	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0230	FDA UDI	Class II	Active
Glidewell™ 3DP Denture Teeth Resin	70-1164-GBD0016	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0147	FDA UDI	Class II	Active
Inclusive	70-1051-COM0214	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0109	FDA UDI	Class II	Unknown
Inclusive	70-1050-COM0074	FDA UDI	Class II	Active
Inclusive	70-1048-COM0177	FDA UDI	Class I	Unknown
Hahn	70-1071-SRG0175	FDA UDI	Class I	Active
BruxZir Esthetic NOW	70-1182-NOW0009	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0073	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0354	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0273	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.