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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 88 of 112

Device	Model / Reference	Registries	Class	Status
Glidewell IH™	70-1074-PRS0099	FDA UDI	Class I	Active
Inclusive®	70-1196-COM0004	FDA UDI	Class II	Active
Inclusive	70-1047-COM0160	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0030	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0016	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0026	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0920	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0471	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0390	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0127	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0662	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0277	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0011	FDA UDI	Class II	Unknown
Inclusive®	70-1171-COM0001	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0119	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0395	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0024	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0026	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0003	FDA UDI	Class II	Active
Inclusive	70-1047-COM0002	FDA UDI	Class II	Active
Inclusive	70-1176-COM0285	FDA UDI	Class II	Active
Inclusive	70-1052-COM0090	FDA UDI	Class II	Active
BruxZir	70-1116-BXS0112	FDA UDI	Class II	Active
Inclusive	70-1052-COM0047	FDA UDI	Class II	Active
Inclusive	70-1053-COM0060	FDA UDI	Class II	Active
Hahn	70-1153-PRS0013	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0090	FDA UDI	Class I	Active
BruxZir	70-1185-BXP0572	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0163	FDA UDI	Class II	Unknown
BruxZir NOW	70-1184-NOW0004	FDA UDI	Class II	Active
Hahn	70-1153-PRA0088	FDA UDI	Class II	Active
Inclusive	70-1051-COM0095	FDA UDI	Class II	Active
Inclusive	70-1051-COM0193	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0288	FDA UDI	Class II	Active
Glidewell IH™	70-1206-IMP0022	FDA UDI	Class II	Active
Inclusive	70-1051-COM0126	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0037	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0344	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0009	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0087	FDA UDI	Class II	Active
Glidewell HT™	70-1174-SRG0029	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0123	FDA UDI	Class I	Active
Glidewell HT™	70-1190-IMP0008	FDA UDI	Class II	Active
Hahn	70-1153-PRA0048	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0306	FDA UDI	Class II	Unknown
Inclusive	70-1053-COM0103	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0243	FDA UDI	Class II	Active
Inclusive	70-1051-COM0189	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0279	FDA UDI	Class II	Unknown
Inclusive	70-1153-PRA0073	FDA UDI	Class I	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.