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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 29 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0534	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0372	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0113	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0713	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0068	FDA UDI	Class I	Active
Hahn	70-1071-SRG0228	FDA UDI	Class I	Active
Inclusive	70-1050-COM0031	FDA UDI	Class II	Active
BruxZir	4400179	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0002	FDA UDI	Class I	Active
Glidewell IH™	70-1206-IMP0025	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0126	FDA UDI	Class II	Active
Inclusive	70-1176-COM0329	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0129	FDA UDI	Class II	Active
BruxZir	70-1013-BRX0015	FDA UDI	Class II	Unknown
Inclusive	70-1067-MNI0001	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0388	FDA UDI	Class I	Active
BruxZir	70-1117-BXS0059	FDA UDI	Class II	Unknown
BruxZir	70-1167-NOW0015	FDA UDI	Class II	Unknown
Inclusive	70-1139-COM0032	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0029	FDA UDI	Class I	Active
BruxZir	70-1014-BRX0011	FDA UDI	Class I	Active
Inclusive®	70-1192-COM0033	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0006	FDA UDI	Class II	Unknown
Inclusive	70-1053-COM0099	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0403	FDA UDI	Class II	Active
Inclusive	70-1176-COM0252	FDA UDI	Class I	Active
Hahn	70-1154-IMP0003	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0030	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0004	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0040	FDA UDI	Class I	Unknown
BruxZir®	70-1182-BZE0162	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0012	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0069	FDA UDI	Class II	Active
BruxZir™ Opaque Coloring Liquid	70-1123-BRX0005	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0024	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0063	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0112	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0011	FDA UDI	Class II	Active
BruxZir	70-1014-BRX0016	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0043	FDA UDI	Class I	Active
Inclusive	70-1047-COM0214	FDA UDI	Class I	Active
Inclusive	70-1173-COM0024	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0005	FDA UDI	Class II	Active
Hahn	70-1153-IMP0012	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0041	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0010	FDA UDI	Class II	Unknown
Inclusive	70-1047-COM0158	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0220	FDA UDI	Class II	Active
Glidewell™ 3DP Denture Teeth Resin Shade A3	70-1164-GBD0006	FDA UDI	Class II	Active
Inclusive	70-1047-COM0172	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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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.