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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 87 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir®	70-1185-NOW0132	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0095	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0144	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0688	FDA UDI	Class II	Unknown
Inclusive®	70-1194-COM0010	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0690	FDA UDI	Class II	Unknown
BruxZir	70-1159-BXA0014	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0014	FDA UDI	Class II	Unknown
BruxZir	70-1158-BXA0034	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0015	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0118	FDA UDI	Class I	Active
BruxZir	70-1130-BRX0002	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0167	FDA UDI	Class II	Active
Inclusive	70-1051-COM0195	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0822	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0041	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0010	FDA UDI	Class II	Active
Inclusive	70-1051-COM0094	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0017	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0164	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0004	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0008	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0035	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0029	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0173	FDA UDI	Class I	Unknown
Glidewell HT™	70-1190-PRS0022	FDA UDI	Class II	Active
BruxZir NOW	70-1182-NOW0020	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0005	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0145	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0187	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0039	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0079	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0209	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0128	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0516	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0182	FDA UDI	Class II	Unknown
Inclusive	70-1050-COM0095	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0327	FDA UDI	Class II	Active
Inclusive	70-1051-COM0156	FDA UDI	Class I	Unknown
Glidewell™ 3DP Denture Teeth Resin	70-1164-GBD0014	FDA UDI	Class II	Active
Hahn	70-1071-SRG0210	FDA UDI	Class I	Active
Inclusive	70-1066-MNI0001	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0023	FDA UDI	Class II	Active
Inclusive	70-1051-COM0218	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0285	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0084	FDA UDI	Class II	Active
Inclusive	70-1051-COM0271	FDA UDI	Class I	Active
Inclusive	70-1052-COM0045	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0064	FDA UDI	Class II	Active
Inclusive	70-1147-COM0078	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.