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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 73 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1072-PRC0049	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0076	FDA UDI	Class I	Unknown
Inclusive®	70-1171-COM0017	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0291	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0171	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0183	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0041	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0460	FDA UDI	Class II	Active
Inclusive	70-1055-COM0035	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0951	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0056	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0112	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0073	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0090	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0536	FDA UDI	Class II	Active
Hahn	70-1071-SRG0185	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0384	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0563	FDA UDI	Class II	Active
Inclusive	70-1054-COM0116	FDA UDI	Class I	Unknown
Glidewell HT™	70-1071-SRG0364	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0283	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0082	FDA UDI	Class II	Active
Inclusive®	70-1056-COM0017	FDA UDI	Class II	Active
Inclusive	70-1048-COM0147	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0179	FDA UDI	Class II	Active
ACE Surgical	207455	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0196	FDA UDI	Class II	Active
Inclusive	70-1051-COM0128	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0156	FDA UDI	Class II	Unknown
BruxZir	70-1119-BXS0077	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0152	FDA UDI	Class II	Unknown
Glidewell IH™	70-1206-IMP0015	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0103	FDA UDI	Class II	Active
Inclusive	70-1139-COM0039	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0913	FDA UDI	Class II	Active
Inclusive	70-1054-COM0061	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0021	FDA UDI	Class I	Active
Inclusive®	70-1178-COM0001	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0107	FDA UDI	Class II	Active
Hahn	70-1153-PRA0121	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0354	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0062	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0138	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0135	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0152	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0074	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0001	FDA UDI	Class II	Active
Inclusive	70-1051-COM0158	FDA UDI	Class I	Active
Inclusive	70-1052-COM0064	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0031	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.