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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 76 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1139-COM0052	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0012	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0542	FDA UDI	Class II	Active
Newport Biologics Resorbable Collagen Membrane 34	70-BIO-2030R34	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0241	FDA UDI	Class II	Active
Inclusive	70-1176-COM0333	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0008	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0008	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0153	FDA UDI	Class II	Active
Inclusive	70-1176-COM0223	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0015	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0047	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0081	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0019	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0029	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0064	FDA UDI	Class I	Active
BruxZir	70-1117-BXS0118	FDA UDI	Class II	Active
Inclusive	70-1054-COM0070	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0034	FDA UDI	Class II	Active
Glidewell IH™	70-1195-PRC0001	FDA UDI	Class I	Active
BruxZir	70-1155-BXA0016	FDA UDI	Class II	Active
Inclusive	70-1053-COM0046	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0003	FDA UDI	Class II	Active
Inclusive	70-1050-COM0098	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0015	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRA0074	FDA UDI	Class I	Active
Hahn	70-1153-PRA0069	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0278	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0073	FDA UDI	Class I	Unknown
Glidewell IH™	70-1072-PRC0080	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0419	FDA UDI	Class I	Active
Hahn	70-1071-SRG0176	FDA UDI	Class I	Active
Hahn	70-1153-PRA0076	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0068	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0063	FDA UDI	Class I	Active
Inclusive	70-1052-COM0080	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0551	FDA UDI	Class II	Active
Inclusive	70-1050-COM0066	FDA UDI	Class I	Active
Obsidian	70-1122-OMB0152	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0325	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0271	FDA UDI	Class II	Unknown
Inclusive	70-1054-COM0101	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0077	FDA UDI	Class II	Active
Inclusive	70-1053-COM0040	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0109	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0106	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0094	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0175	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0116	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0086	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.