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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 70 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1135-CAM0019	FDA UDI	Class II	Active
Inclusive®	70-1169-COM0010	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0120	FDA UDI	Class II	Unknown
Glidewell IH™	70-1074-PRS0087	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0552	FDA UDI	Class II	Active
Inclusive®	70-1195-COM0029	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0151	FDA UDI	Class II	Active
Inclusive	70-1139-COM0027	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0267	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0432	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0324	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0021	FDA UDI	Class II	Active
Hahn	70-1153-PRC0051	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0414	FDA UDI	Class II	Active
Hahn	70-1153-PRS0010	FDA UDI	Class II	Active
BruxZir	70-1167-NOW0021	FDA UDI	Class II	Unknown
Inclusive	70-1053-COM0097	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0497	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0953	FDA UDI	Class II	Active
Hahn	70-1071-SRG0198	FDA UDI	Class I	Active
Hahn	70-1071-SRG0064	FDA UDI	Class I	Active
Hahn	70-1153-PRA0012	FDA UDI	Class II	Active
Hahn	70-1071-SRG0216	FDA UDI	Class I	Active
Hahn	70-1071-SRG0081	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0049	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0011	FDA UDI	Class II	Active
Inclusive	70-1047-COM0127	FDA UDI	Class I	Active
BruxZir	70-1116-BXS0095	FDA UDI	Class II	Active
BruxZir	4400068	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0825	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0038	FDA UDI	Class II	Active
Inclusive	70-1051-COM0003	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0505	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0043	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0014	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0113	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0360	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0620	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0083	FDA UDI	Class II	Unknown
BruxZir	70-1155-BXA0011	FDA UDI	Class II	Active
Inclusive	70-1052-COM0142	FDA UDI	Class I	Active
ACE Surgical	30433	FDA UDI	Class II	Active
BruxZir	70-1157-BXA0021	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0689	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0103	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0022	FDA UDI	Class II	Active
Inclusive	70-1139-COM0057	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0128	FDA UDI	Class II	Active
Inclusive	70-1051-COM0212	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0409	FDA UDI	Class I	Active

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.