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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 33 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Shaded 16 PLUS	70-1185-BXP0087	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0158	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0077	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0017	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0006	FDA UDI	Class II	Active
Glidewell IH™	70-1207-IMP0016	FDA UDI	Class II	Active
Inclusive	70-1052-COM0072	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0045	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0194	FDA UDI	Class II	Active
Inclusive	70-1051-COM0261	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0317	FDA UDI	Class II	Unknown
Inclusive®	70-1052-COM0160	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0011	FDA UDI	Class II	Unknown
BruxZir	70-1155-BXA0002	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0223	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0019	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0324	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0355	FDA UDI	Class II	Active
Inclusive	70-1047-COM0156	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0081	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0015	FDA UDI	Class II	Active
Inclusive	70-1068-IMP0001	FDA UDI	Class II	Active
Inclusive	70-1147-COM0054	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0207	FDA UDI	Class I	Active
ACE Surgical	3010502	FDA UDI	Class I	Active
Inclusive	70-1047-COM0146	FDA UDI	Class II	Active
Inclusive	70-1048-COM0133	FDA UDI	Class I	Active
Inclusive	70-1054-COM0069	FDA UDI	Class II	Active
Inclusive	70-1049-COM0080	FDA UDI	Class I	Active
Inclusive	70-1176-COM0251	FDA UDI	Class I	Active
Hahn	70-1154-IMP0014	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0064	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0005	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0084	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0015	FDA UDI	Class I	Active
BruxZir™ TintEFX Coloring Liquid	70-1123-BRX0036	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0008	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0683	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0558	FDA UDI	Class II	Unknown
Inclusive®	70-1190-COM0034	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0052	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0161	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0717	FDA UDI	Class II	Unknown
Glidewell IH™	70-1207-IMP0019	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0033	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0004	FDA UDI	Class II	Active
Inclusive	70-1048-COM0174	FDA UDI	Class I	Unknown
Hahn	70-1071-SRG0188	FDA UDI	Class I	Active
BruxZir	70-1160-BXA0026	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0021	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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.