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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 82 of 112

Device	Model / Reference	Registries	Class	Status
CAMouflage	70-1000-CMN0015	FDA UDI	Class II	Active
Hahn	70-1153-PRC0042	FDA UDI	Class I	Active
Inclusive	70-1050-COM0079	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0040	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0030	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0010	FDA UDI	Class I	Active
Inclusive	70-1147-COM0099	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0435	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0086	FDA UDI	Class II	Active
Inclusive	70-1147-COM0089	FDA UDI	Class I	Active
BruxZir NOW	70-1167-NOW0078	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0060	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0043	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0065	FDA UDI	Class II	Active
Inclusive	70-1054-COM0104	FDA UDI	Class I	Active
CAMouflage	70-1000-CMN0034	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0026	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0020	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0111	FDA UDI	Class II	Unknown
Inclusive®	70-1194-COM0024	FDA UDI	Class II	Active
Inclusive	70-1139-COM0017	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0323	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0404	FDA UDI	Class II	Active
Inclusive	70-1050-COM0096	FDA UDI	Class II	Active
Inclusive	70-1139-COM0034	FDA UDI	Class II	Active
BruxZir™ Opaque Coloring Liquid	70-1123-BRX0001	FDA UDI	Class II	Active
Inclusive	70-1139-COM0051	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0163	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0679	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0155	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0085	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0065	FDA UDI	Class II	Active
BruxZir	4400194	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0970	FDA UDI	Class II	Active
Inclusive	70-1054-COM0074	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0126	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0025	FDA UDI	Class II	Active
Glidewell HT™	70-1189-IMP0015	FDA UDI	Class II	Active
BruxZir	70-1013-BRX0001	FDA UDI	Class II	Unknown
Inclusive®	70-1056-COM0024	FDA UDI	Class II	Active
Hahn	70-1071-SRG0218	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0297	FDA UDI	Class II	Active
Inclusive	70-1047-COM0141	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0122	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0087	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0004	FDA UDI	Class II	Active
Inclusive	70-1051-COM0270	FDA UDI	Class I	Active
Inclusive	70-1072-PRC0051	FDA UDI	Class I	Active
Obsidian	70-1122-OMB0160	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0518	FDA UDI	Class II	Active

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Authorised Representatives

No authorised representatives on record.

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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.