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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 31 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1049-COM0049	FDA UDI	Class II	Active
Inclusive	70-1147-COM0073	FDA UDI	Class II	Active
Inclusive	70-1048-COM0091	FDA UDI	Class II	Active
BruxZir	70-1015-BRX0012	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0022	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0014	FDA UDI	Class I	Active
Inclusive	70-1051-COM0101	FDA UDI	Class II	Active
Inclusive	70-1051-COM0020	FDA UDI	Class II	Active
Inclusive	70-1053-COM0095	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0397	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0003	FDA UDI	Class I	Active
BruxZir	4400197	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0437	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0072	FDA UDI	Class II	Active
Inclusive	70-1051-COM0220	FDA UDI	Class I	Unknown
Hahn	70-1154-IMP0016	FDA UDI	Class II	Active
Hahn	70-1071-SRG0062	FDA UDI	Class I	Active
Inclusive®	70-1194-COM0021	FDA UDI	Class I	Active
Inclusive	70-1047-COM0093	FDA UDI	Class II	Active
BruxZir	70-1159-BXA0026	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0038	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0073	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0047	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0029	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0063	FDA UDI	Class II	Active
Hahn	70-1071-SRG0063	FDA UDI	Class I	Active
BruxZir	70-1175-BZA0001	FDA UDI	Class II	Active
Camouflage	70-1151-CMU0018	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0549	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0387	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0046	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0018	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0430	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0047	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0026	FDA UDI	Class I	Active
Inclusive®	70-1195-COM0005	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0021	FDA UDI	Class II	Active
Inclusive®	70-1192-COM0030	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0042	FDA UDI	Class II	Active
Inclusive	70-1054-COM0005	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0022	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0658	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0496	FDA UDI	Class II	Active
Hahn	70-1153-PRA0053	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0158	FDA UDI	Class II	Unknown
Hahn	70-1153-PRA0060	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0348	FDA UDI	Class I	Active
Obsidian	70-1124-PUS0046	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0063	FDA UDI	Class II	Active
Inclusive	70-1047-COM0094	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

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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.