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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 65 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1173-COM0008	FDA UDI	Class I	Active
BruxZir	70-1119-BXS0057	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0207	FDA UDI	Class II	Active
BruxZir GT Color	70-1123-BCL0035	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0016	FDA UDI	Class II	Active
Inclusive	70-1051-COM0002	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0139	FDA UDI	Class II	Active
Hahn	70-1071-SRG0066	FDA UDI	Class I	Active
Newport Biologics Bone Graft Putty Mineral Collagen Composite	70-BIO-BGP05	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0027	FDA UDI	Class II	Unknown
Hahn	70-1071-SRG0089	FDA UDI	Class I	Active
Inclusive	70-1050-COM0142	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0275	FDA UDI	Class I	Active
Inclusive	70-1047-COM0163	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0157	FDA UDI	Class II	Unknown
Inclusive	70-1047-COM0177	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0122	FDA UDI	Class II	Active
Inclusive®	70-1194-COM0029	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0141	FDA UDI	Class II	Unknown
BruxZir	70-1159-BXA0019	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0014	FDA UDI	Class II	Unknown
Glidewell HT™	70-1071-SRG0292	FDA UDI	Class I	Active
Inclusive	70-1051-COM0120	FDA UDI	Class I	Active
Hahn	70-1071-SRG0076	FDA UDI	Class I	Active
BruxZir®	70-1182-NOW0074	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0113	FDA UDI	Class II	Active
Hahn	70-1153-PRC0055	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRA0029	FDA UDI	Class I	Active
Inclusive	70-1070-IMP0026	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0133	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0071	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0062	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0145	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0421	FDA UDI	Class I	Active
Inclusive®	70-1074-PRS0075	FDA UDI	Class I	Unknown
Inclusive	70-1047-COM0136	FDA UDI	Class II	Active
Inclusive	70-1147-COM0027	FDA UDI	Class II	Active
Inclusive	70-1047-COM0170	FDA UDI	Class I	Active
Inclusive	70-1174-SRG0016	FDA UDI	Class I	Active
Biotemps	70-1181-MIL0029	FDA UDI	Class II	Active
BruxZir NOW	70-1167-NOW0094	FDA UDI	Class II	Active
Inclusive	70-1139-COM0006	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0045	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0033	FDA UDI	Class II	Active
Glidewell™ 3DP Denture Base Resin - Shade G3	70-1164-GBD0002	FDA UDI	Class II	Active
Inclusive®	70-1071-SRG0400	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0297	FDA UDI	Class II	Unknown
Inclusive®	70-1172-COM0050	FDA UDI	Class II	Active
BruxZir	70-1156-BXA0025	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0169	FDA UDI	Class II	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.