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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 35 of 112

Device	Model / Reference	Registries	Class	Status
Hahn	70-1071-SRG0056	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0318	FDA UDI	Class I	Active
Hahn	70-1071-SRG0090	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0105	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0271	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0352	FDA UDI	Class I	Active
Inclusive	70-1050-COM0101	FDA UDI	Class II	Active
Hahn	70-1071-SRG0217	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0299	FDA UDI	Class II	Active
Inclusive	70-1054-COM0085	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0009	FDA UDI	Class II	Active
Inclusive	70-1048-COM0158	FDA UDI	Class II	Active
Hahn	70-1153-PRC0003	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0111	FDA UDI	Class II	Active
Inclusive	70-1049-COM0047	FDA UDI	Class I	Active
Obsidian	70-1122-OMB0011	FDA UDI	Class II	Active
Inclusive®	70-1169-COM0011	FDA UDI	Class I	Active
Inclusive	70-1139-COM0061	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0023	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0153	FDA UDI	Class I	Active
Inclusive	70-1047-COM0081	FDA UDI	Class II	Active
Inclusive®	70-1193-COM0002	FDA UDI	Class II	Active
BruxZir NOW	70-1184-NOW0007	FDA UDI	Class II	Active
Inclusive	70-1147-COM0050	FDA UDI	Class II	Active
BruxZir	70-1186-BXP0306	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0024	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0014	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0004	FDA UDI	Class I	Active
Inclusive	70-1147-COM0077	FDA UDI	Class II	Active
Glidewell IH™	70-1074-PRS0098	FDA UDI	Class I	Active
Inclusive	70-1048-COM0176	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0031	FDA UDI	Class II	Active
Inclusive	70-1047-COM0179	FDA UDI	Class I	Unknown
Glidewell HT™	70-1190-PRA0012	FDA UDI	Class II	Active
Inclusive	70-1176-COM0388	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0185	FDA UDI	Class I	Active
Inclusive	70-1173-COM0003	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0035	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0157	FDA UDI	Class II	Active
Hahn	70-1154-IMP0007	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0357	FDA UDI	Class II	Active
Glidewell IH™	70-1072-PRC0085	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0455	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0374	FDA UDI	Class II	Unknown
Inclusive®	70-1171-COM0006	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0570	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0125	FDA UDI	Class II	Active
Inclusive®	70-1171-COM0016	FDA UDI	Class I	Active
Hahn	70-1153-PRS0017	FDA UDI	Class II	Active
Inclusive	70-1176-COM0315	FDA UDI	Class I	Active

Related Companies

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.