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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 25 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir®	70-1182-BZE0172	FDA UDI	Class II	Unknown
Inclusive	70-1048-COM0002	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0439	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0050	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0103	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0057	FDA UDI	Class II	Active
Inclusive	70-1051-COM0043	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0643	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0015	FDA UDI	Class II	Active
Inclusive	70-1047-COM0100	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0706	FDA UDI	Class II	Unknown
Inclusive	70-1135-CAM0180	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0047	FDA UDI	Class II	Active
Inclusive	70-1053-COM0026	FDA UDI	Class I	Active
BruxZir	4400198	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0115	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0132	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0051	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0208	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0015	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0071	FDA UDI	Class I	Active
BruxZir Esthetic NOW	70-1182-NOW0013	FDA UDI	Class II	Active
Inclusive	70-1173-COM0039	FDA UDI	Class II	Active
BruxZir	70-1014-BRX0013	FDA UDI	Class I	Active
Inclusive	70-1074-PRS0057	FDA UDI	Class I	Active
Inclusive	70-1047-COM0138	FDA UDI	Class II	Active
Inclusive	70-1047-COM0219	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0117	FDA UDI	Class II	Active
Inclusive	70-1048-COM0152	FDA UDI	Class II	Active
Inclusive	70-1139-COM0023	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0389	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0007	FDA UDI	Class II	Unknown
Inclusive	70-1055-COM0037	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0929	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0686	FDA UDI	Class II	Unknown
Inclusive	70-1054-COM0172	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0001	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0027	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0006	FDA UDI	Class I	Active
Inclusive	70-1048-COM0123	FDA UDI	Class II	Active
Camouflage	70-1152-CMF0002	FDA UDI	Class II	Active
Glidewell HT™	70-1190-IMP0012	FDA UDI	Class II	Active
Inclusive	70-1048-COM0069	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0670	FDA UDI	Class II	Unknown
Inclusive	70-1068-IMP0002	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0054	FDA UDI	Class I	Active
Inclusive	70-1050-COM0097	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0022	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0337	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0043	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.