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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 68 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive®	70-1192-COM0011	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0011	FDA UDI	Class II	Active
Inclusive	70-1047-COM0159	FDA UDI	Class II	Active
Hahn	70-1071-SRG0059	FDA UDI	Class I	Active
Obsidian	70-1124-PUS0066	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0818	FDA UDI	Class II	Active
Inclusive	70-1173-COM0005	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0943	FDA UDI	Class II	Active
Glidewell IH™	70-1206-IMP0023	FDA UDI	Class II	Active
Inclusive	70-1048-COM0207	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0008	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0815	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0008	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0014	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0960	FDA UDI	Class II	Active
Inclusive	70-1173-COM0017	FDA UDI	Class II	Active
Inclusive	70-1047-COM0062	FDA UDI	Class II	Active
Glidewell IH™	70-1206-IMP0013	FDA UDI	Class II	Active
Flexible Partial Resin	70-1164-RSN0009	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0037	FDA UDI	Class II	Active
Inclusive	70-1051-COM0087	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0006	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0057	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0349	FDA UDI	Class II	Active
Inclusive	70-1053-COM0047	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0369	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0656	FDA UDI	Class II	Active
Inclusive®	70-1052-COM0155	FDA UDI	Class II	Active
Inclusive	70-1052-COM0074	FDA UDI	Class II	Active
Inclusive	70-1069-IMP0012	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0578	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0006	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0103	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0127	FDA UDI	Class II	Active
Inclusive	70-1051-COM0155	FDA UDI	Class I	Unknown
Obsidian	70-1122-OMB0156	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0172	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0144	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0424	FDA UDI	Class II	Active
Inclusive	70-1054-COM0102	FDA UDI	Class I	Active
Inclusive®	70-1171-COM0002	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0508	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0113	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0704	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0088	FDA UDI	Class II	Active
Inclusive®	70-1074-PRS0074	FDA UDI	Class I	Active
Hahn	70-1071-SRG0200	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0021	FDA UDI	Class I	Active
Inclusive	70-1054-COM0165	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0099	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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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.