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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 69 of 112

Device	Model / Reference	Registries	Class	Status
Obsidian	70-1124-PUS0070	FDA UDI	Class II	Active
Inclusive	70-1056-COM0012	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0187	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0165	FDA UDI	Class I	Active
Inclusive	70-1051-COM0176	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0168	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0582	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0619	FDA UDI	Class II	Active
Inclusive	70-1053-COM0074	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0181	FDA UDI	Class I	Unknown
Inclusive	70-1053-COM0018	FDA UDI	Class I	Active
Hahn	70-1153-PRC0047	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0074	FDA UDI	Class I	Active
Inclusive	70-1176-COM0267	FDA UDI	Class I	Active
Inclusive	70-1176-COM0239	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0192	FDA UDI	Class II	Unknown
Hahn	70-1153-PRC0038	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0121	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0268	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0039	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0542	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0118	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0218	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0280	FDA UDI	Class II	Unknown
Inclusive	70-1176-COM0276	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0154	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0919	FDA UDI	Class II	Active
Inclusive	70-1068-IMP0008	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0044	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0294	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0307	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0270	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0142	FDA UDI	Class II	Active
Inclusive	70-1176-COM0273	FDA UDI	Class I	Active
Hahn	70-1153-PRA0057	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0181	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0175	FDA UDI	Class I	Unknown
BruxZir	70-1138-BSA0197	FDA UDI	Class II	Unknown
Inclusive®	70-1169-COM0007	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0049	FDA UDI	Class II	Active
Inclusive	70-1051-COM0108	FDA UDI	Class I	Active
Inclusive	70-1176-COM0234	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0199	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0134	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0444	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0321	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0369	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0137	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0074	FDA UDI	Class I	Unknown
Inclusive	70-1135-CAM0235	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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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.