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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 24 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Esthetic	70-1183-BEP0016	FDA UDI	Class II	Unknown
Inclusive	70-1153-PRA0024	FDA UDI	Class I	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0081	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0260	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0299	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0010	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0531	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0450	FDA UDI	Class II	Active
Hahn	70-1153-PRC0066	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0158	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0036	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0184	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0165	FDA UDI	Class II	Active
Inclusive	70-1176-COM0245	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0182	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0143	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0054	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0036	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0140	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0541	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0133	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0382	FDA UDI	Class II	Unknown
BruxZir	70-1013-BRX0005	FDA UDI	Class II	Unknown
Hahn	70-1153-PRA0063	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0038	FDA UDI	Class II	Active
Inclusive®	70-1196-COM0005	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0007	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0541	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0703	FDA UDI	Class II	Unknown
Inclusive	70-1047-COM0135	FDA UDI	Class II	Active
Hahn	70-1153-PRC0023	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0114	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0083	FDA UDI	Class II	Active
Inclusive	70-1069-IMP0016	FDA UDI	Class II	Active
Inclusive	70-1139-COM0013	FDA UDI	Class II	Active
Hahn	70-1153-PRC0070	FDA UDI	Class I	Active
Inclusive	70-1074-PRS0044	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0178	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0097	FDA UDI	Class II	Active
Hahn	70-1071-SRG0214	FDA UDI	Class I	Active
Inclusive	70-1049-COM0011	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0010	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0041	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0136	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0273	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0189	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0315	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0086	FDA UDI	Class II	Active
Flexible Partial Resin	70-1164-RSN0008	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0170	FDA UDI	Class II	Active

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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.