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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 74 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive®	70-1178-COM0005	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0068	FDA UDI	Class II	Active
Hahn	70-1071-SRG0187	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0019	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0119	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0153	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0131	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0251	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0180	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0116	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0261	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0060	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0098	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0157	FDA UDI	Class II	Unknown
Capture	70-1031-CAP0021	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0025	FDA UDI	Class II	Active
Inclusive	70-1153-PRA0070	FDA UDI	Class I	Active
Inclusive	70-1147-COM0091	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0040	FDA UDI	Class II	Active
Inclusive	70-1139-COM0045	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0071	FDA UDI	Class II	Active
Inclusive	70-1147-COM0066	FDA UDI	Class II	Active
Inclusive	70-1070-IMP0028	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0005	FDA UDI	Class II	Active
Inclusive	70-1048-COM0173	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0108	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0077	FDA UDI	Class II	Active
Inclusive	70-1054-COM0099	FDA UDI	Class I	Active
Inclusive®	70-1194-COM0030	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0035	FDA UDI	Class II	Active
Hahn	70-1071-SRG0220	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0113	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0154	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0020	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0153	FDA UDI	Class II	Unknown
Inclusive	70-1050-COM0011	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0333	FDA UDI	Class I	Active
BruxZir	70-1010-BRX0097	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0045	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0003	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0020	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0592	FDA UDI	Class II	Active
Inclusive	70-1054-COM0162	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0896	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0950	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0016	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0218	FDA UDI	Class II	Active
Inclusive®	70-1056-COM0021	FDA UDI	Class II	Active
Obsidian	701124PUS0095	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0007	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

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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.