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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 85 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1052-COM0151	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0146	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0017	FDA UDI	Class II	Active
Hahn	70-1153-PRC0043	FDA UDI	Class I	Active
Inclusive	70-1072-PRC0043	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0150	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0129	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0170	FDA UDI	Class II	Active
Inclusive	70-1052-COM0050	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0075	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0143	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0116	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0085	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0031	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0256	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0133	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0095	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0501	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0037	FDA UDI	Class I	Active
Inclusive®	70-1194-COM0038	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0015	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0165	FDA UDI	Class II	Active
Inclusive	70-1176-COM0218	FDA UDI	Class I	Unknown
Hahn	70-1071-SRG0189	FDA UDI	Class I	Active
Inclusive	70-1050-COM0073	FDA UDI	Class I	Active
Inclusive®	70-1194-COM0028	FDA UDI	Class I	Active
Glidewell IH™	70-1207-IMP0018	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0022	FDA UDI	Class II	Active
Inclusive	70-1176-COM0225	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0064	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0151	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0070	FDA UDI	Class II	Unknown
Inclusive	70-1050-COM0046	FDA UDI	Class II	Active
Biotemps	70-1181-MIL0028	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0026	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0038	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0205	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0303	FDA UDI	Class II	Active
Inclusive	70-1050-COM0076	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0080	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0270	FDA UDI	Class II	Active
Inclusive	70-1052-COM0030	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0014	FDA UDI	Class II	Active
Hahn	70-1153-PRA0066	FDA UDI	Class I	Active
BruxZir	70-1160-BXA0027	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0375	FDA UDI	Class I	Active
Inclusive	70-1051-COM0164	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0145	FDA UDI	Class II	Active
Inclusive	70-1051-COM0050	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0218	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.