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PRISMATIK DENTALCRAFT, INC.

Last updated September 17, 2026

What PRISMATIK DENTALCRAFT, INC. makes

Prismatik Dentalcraft produces ceramic materials for dental appliance fabrication, including preformed temporary and permanent suprastructures for dental implants. Their portfolio also includes intraoral-scanning abutment analogs, reusable dental drill bits, and single-use dental prosthesis abutment screws. The company offers complete dental implant systems and analog components for implant planning and fitting.

Their devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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 71 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive®	70-1190-COM0011	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0001	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0014	FDA UDI	Class II	Active
Inclusive	70-1051-COM0165	FDA UDI	Class I	Active
Inclusive	70-1051-COM0182	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0022	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0221	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0150	FDA UDI	Class II	Unknown
BruxZir	70-1118-BXS0053	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0312	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0009	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0961	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0109	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0094	FDA UDI	Class II	Unknown
Inclusive	70-1073-PRA0021	FDA UDI	Class I	Active
BruxZir	70-1014-BRX0017	FDA UDI	Class I	Active
BruxZir	70-1158-BXA0019	FDA UDI	Class II	Active
Inclusive	70-1049-COM0025	FDA UDI	Class II	Active
Metal Quadrant Impression Trays	70-1026-CAP0010	FDA UDI	Class I	Active
Inclusive	70-1070-IMP0006	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0244	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0157	FDA UDI	Class II	Unknown
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0013	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0164	FDA UDI	Class I	Active
Inclusive	70-1051-COM0210	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0080	FDA UDI	Class II	Active
Inclusive	70-1054-COM0022	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0005	FDA UDI	Class II	Active
Camouflage	70-1152-CMF0016	FDA UDI	Class II	Active
BruxZir	4400199	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0052	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0123	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0424	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0096	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0474	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0644	FDA UDI	Class II	Active
Inclusive®	70-1052-COM0158	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0009	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0034	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0003	FDA UDI	Class II	Active
Inclusive	70-1051-COM0168	FDA UDI	Class I	Active
Glidewell IH™	70-1074-PRS0101	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0940	FDA UDI	Class II	Active
Inclusive	70-1052-COM0094	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0024	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0958	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0171	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0093	FDA UDI	Class II	Active
Inclusive	70-1050-COM0139	FDA UDI	Class I	Active
Glidewell IH™	70-1206-IMP0003	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Authorities

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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.