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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 23 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir Esthetic	70-1183-BEP0179	FDA UDI	Class II	Unknown
Inclusive	70-1050-COM0089	FDA UDI	Class II	Active
Inclusive	70-1176-COM0191	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0163	FDA UDI	Class II	Unknown
Obsidian	70-1122-OMB0155	FDA UDI	Class II	Unknown
BruxZir®	70-1182-BZE0169	FDA UDI	Class II	Active
Hahn	70-1153-PRC0037	FDA UDI	Class I	Active
Inclusive	70-1073-PRA0056	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0326	FDA UDI	Class II	Active
Inclusive	70-1053-COM0032	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0343	FDA UDI	Class II	Unknown
Biotemps	70-1181-MIL0033	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0004	FDA UDI	Class II	Active
Inclusive	70-1176-COM0272	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0121	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0105	FDA UDI	Class II	Active
BruxZir	1014-BRX0016	FDA UDI	Class I	Active
Inclusive	70-1071-SRG0162	FDA UDI	Class I	Active
Inclusive®	70-1169-COM0008	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0065	FDA UDI	Class II	Active
Glidewell HT™	70-1174-SRG0027	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0057	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0574	FDA UDI	Class II	Active
Inclusive	70-1054-COM0046	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0112	FDA UDI	Class II	Active
Inclusive	70-1052-COM0079	FDA UDI	Class II	Active
Inclusive	70-1051-COM0167	FDA UDI	Class I	Active
Hahn	70-1174-SRG0020	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0558	FDA UDI	Class II	Unknown
BruxZir	70-1160-BXA0005	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0272	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0007	FDA UDI	Class II	Active
Inclusive	70-1048-COM0163	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0361	FDA UDI	Class I	Active
Glidewell HT™	70-1189-IMP0010	FDA UDI	Class II	Active
BruxZir®	70-1184-RAD0040	FDA UDI	Class II	Active
BruxZir	70-1014-BRX0021	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0035	FDA UDI	Class II	Active
Inclusive	70-1048-COM0143	FDA UDI	Class II	Active
ACE Surgical	30503	FDA UDI	Class II	Active
Inclusive	70-1139-COM0050	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0232	FDA UDI	Class I	Active
BruxZir	70-1159-BXA0023	FDA UDI	Class II	Unknown
Inclusive	70-1054-COM0063	FDA UDI	Class II	Active
Inclusive	70-1047-COM0224	FDA UDI	Class II	Active
Hahn	70-1071-SRG0203	FDA UDI	Class I	Active
Inclusive	70-1052-COM0096	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0013	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0636	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0237	FDA UDI	Class II	Unknown

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.