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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 27 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1072-PRC0002	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0029	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0032	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0059	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0441	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0236	FDA UDI	Class I	Active
BruxZir	70-1158-BXA0006	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0016	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0073	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0118	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0120	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0012	FDA UDI	Class II	Active
Inclusive	70-1051-COM0045	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0425	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0028	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0016	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0182	FDA UDI	Class I	Active
Inclusive	70-1176-COM0264	FDA UDI	Class I	Active
Newport Surgical	70-BIO-IBGKIT	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0165	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0069	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0147	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0523	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0220	FDA UDI	Class II	Active
Hahn	70-1153-PRA0038	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0422	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0142	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0210	FDA UDI	Class I	Active
Hahn	70-1153-PRA0065	FDA UDI	Class I	Active
Inclusive	70-1051-COM0116	FDA UDI	Class I	Active
Inclusive®	70-1071-SRG0394	FDA UDI	Class I	Active
Glidewell IH™	70-1207-IMP0017	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0164	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0044	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0122	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0061	FDA UDI	Class II	Unknown
BruxZir	70-1157-BXA0022	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0116	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0063	FDA UDI	Class II	Active
Inclusive	70-1052-COM0078	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0033	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0191	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0083	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0123	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0914	FDA UDI	Class II	Unknown
Inclusive	70-1176-COM0297	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0069	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0936	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0013	FDA UDI	Class II	Active
Inclusive	70-1050-COM0145	FDA UDI	Class II	Active

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.