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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 79 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Shaded 16 PLUS	70-1185-BXP0001	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0023	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0025	FDA UDI	Class II	Active
Inclusive®	70-1071-SRG0403	FDA UDI	Class I	Active
BruxZir	70-1117-BXS0109	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0069	FDA UDI	Class I	Active
BruxZir	1014-BRX0014	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0034	FDA UDI	Class I	Active
Inclusive	70-1047-COM0060	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0017	FDA UDI	Class II	Active
Inclusive	70-1047-COM0112	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0147	FDA UDI	Class II	Unknown
BruxZir	70-1010-BRX0028	FDA UDI	Class II	Unknown
BruxZir NOW	70-1167-NOW0100	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0007	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0366	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0447	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0014	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0626	FDA UDI	Class II	Active
Hahn	70-1153-PRC0034	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0333	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0252	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0001	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0038	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0001	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0935	FDA UDI	Class II	Active
BruxZir	70-1138-BSA-0952	FDA UDI	Class II	Unknown
Inclusive	70-1055-COM0036	FDA UDI	Class I	Unknown
Inclusive	70-1173-COM0016	FDA UDI	Class II	Active
Inclusive	70-1050-COM0087	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0025	FDA UDI	Class I	Active
BruxZir	70-1155-BXA0017	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0118	FDA UDI	Class II	Active
BruxZir Esthetic NOW	70-1182-NOW0007	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0023	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0029	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0009	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRS0006	FDA UDI	Class II	Active
Inclusive	70-1047-COM0120	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0049	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0078	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0470	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0388	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0682	FDA UDI	Class II	Unknown
CAMouflage	70-1000-CMN0016	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0031	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0009	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0931	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0061	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0085	FDA UDI	Class II	Unknown

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.