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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 32 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1047-COM0148	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0051	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0049	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0011	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0067	FDA UDI	Class I	Active
Inclusive	70-1048-COM0064	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0031	FDA UDI	Class I	Active
BruxZir	70-1156-BXA0024	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0017	FDA UDI	Class II	Unknown
Inclusive	70-1147-COM0080	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0025	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0046	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0073	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0122	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0041	FDA UDI	Class II	Unknown
BruxZir	70-1116-BXS0096	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0077	FDA UDI	Class I	Unknown
Glidewell HT™	70-1190-PRA0058	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0043	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRS0021	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0052	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0147	FDA UDI	Class II	Unknown
Inclusive®	70-1056-COM0045	FDA UDI	Class I	Active
BruxZir	70-1175-BZA0004	FDA UDI	Class II	Active
Hahn	70-1153-PRA0052	FDA UDI	Class II	Active
Inclusive	70-1049-COM0066	FDA UDI	Class I	Unknown
CAMouflage	70-1000-CMN0042	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0073	FDA UDI	Class II	Active
Inclusive	70-1052-COM0081	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0022	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0174	FDA UDI	Class II	Active
Inclusive	70-1053-COM0034	FDA UDI	Class II	Active
Hahn	70-1153-PRA0015	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0114	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0639	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0729	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0099	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0065	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0016	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0015	FDA UDI	Class II	Active
Inclusive	70-1052-COM0088	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0041	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0095	FDA UDI	Class I	Active
Inclusive	70-1047-COM0218	FDA UDI	Class II	Active
BruxZir	70-1175-BZA0006	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0035	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0009	FDA UDI	Class II	Active
Inclusive	70-1049-COM0001	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0094	FDA UDI	Class I	Active
Hahn	70-1153-PRC0009	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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.