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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 11 of 112

Device	Model / Reference	Registries	Class	Status
CAMouflage	70-1000-CMN0025	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0165	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0138	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0269	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0146	FDA UDI	Class II	Active
Inclusive	70-1050-COM0147	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0001	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0530	FDA UDI	Class II	Active
Silent Nite Sleep Appliance with Glidewell Hinge	SNGLHGHL	FDA UDI	Class II	Active
Inclusive	70-1050-COM0048	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0084	FDA UDI	Class II	Active
Inclusive	70-1051-COM0232	FDA UDI	Class I	Unknown
Inclusive	70-1135-CAM0123	FDA UDI	Class I	Active
Obsidian	70-1122-OMB0007	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0023	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0132	FDA UDI	Class II	Active
Newport Biologics Resorbable Collagen Membrane 46	70-BIO-1520R46	FDA UDI	Class II	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0025	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0039	FDA UDI	Class II	Unknown
BruxZir	70-1160-BXA0024	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0291	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0025	FDA UDI	Class II	Active
BruxZir	4400172	FDA UDI	Class II	Active
Inclusive	70-1051-COM0199	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0078	FDA UDI	Class I	Unknown
Glidewell IH™	70-1071-SRG0443	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0020	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0367	FDA UDI	Class II	Unknown
Inclusive	70-1053-COM0045	FDA UDI	Class II	Active
Inclusive	70-1047-COM0001	FDA UDI	Class II	Active
Inclusive	70-1176-COM0287	FDA UDI	Class II	Active
Inclusive	70-1053-COM0035	FDA UDI	Class I	Active
BruxZir	70-1157-BXA0008	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0105	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0115	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0071	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0587	FDA UDI	Class II	Active
Inclusive	70-1054-COM0059	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0117	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0692	FDA UDI	Class II	Unknown
Inclusive	70-1176-COM0395	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0155	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0685	FDA UDI	Class II	Unknown
Inclusive	70-1176-COM0215	FDA UDI	Class I	Unknown
Inclusive	70-1052-COM0020	FDA UDI	Class II	Active
Hahn	70-1153-PRC0058	FDA UDI	Class I	Active
BruxZir	70-1118-BXS0079	FDA UDI	Class II	Unknown
Glidewell IH™	70-1073-PRA0104	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0014	FDA UDI	Class II	Active
Inclusive	70-1051-COM0208	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.