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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 30 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1055-COM0029	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0819	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0015	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0190	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0093	FDA UDI	Class II	Active
Inclusive	70-1066-MNP0011	FDA UDI	Class I	Active
Obsidian	70-1124-PUS0064	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0016	FDA UDI	Class II	Active
Inclusive	70-1050-COM0051	FDA UDI	Class II	Active
Inclusive	70-1176-COM0398	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0168	FDA UDI	Class II	Active
Hahn	70-1071-SRG0201	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0052	FDA UDI	Class II	Active
Inclusive	70-1147-COM0030	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0043	FDA UDI	Class II	Active
Glidewell Restorative CT	70-1152-CTS0001	FDA UDI	Class II	Active
Inclusive	70-1176-COM0230	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0392	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0642	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0328	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0299	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0136	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0036	FDA UDI	Class I	Active
Hahn	70-1153-PRC0062	FDA UDI	Class I	Active
BruxZir	70-1138-BSA-0948	FDA UDI	Class II	Unknown
Glidewell HT™	70-1190-PRC0003	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0047	FDA UDI	Class I	Active
Inclusive	70-1047-COM0126	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0108	FDA UDI	Class II	Active
Biotemps	70-1181-MIL0034	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0009	FDA UDI	Class I	Active
Inclusive	70-1069-IMP0017	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0026	FDA UDI	Class I	Active
BruxZir	70-1013-BRX0003	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0224	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0035	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0048	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0092	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0894	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0103	FDA UDI	Class II	Active
Inclusive	70-1048-COM0138	FDA UDI	Class II	Active
Inclusive	70-1176-COM0279	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0157	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0004	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0120	FDA UDI	Class II	Active
Inclusive	70-1048-COM0142	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0176	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1186-BXP0119	FDA UDI	Class II	Unknown
Hahn	70-1071-SRG0078	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0011	FDA UDI	Class II	Unknown

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.