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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 80 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir NOW	70-1182-NOW0023	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0517	FDA UDI	Class II	Active
Inclusive	70-1054-COM0006	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0291	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0197	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0077	FDA UDI	Class II	Unknown
Obsidian	70-1121-OBP0091	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0208	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0293	FDA UDI	Class I	Active
Hahn	70-1153-PRA0042	FDA UDI	Class II	Active
Hahn	70-1154-IMP0021	FDA UDI	Class II	Active
Inclusive	70-1176-COM0408	FDA UDI	Class I	Active
Inclusive	70-1176-COM0327	FDA UDI	Class II	Active
Inclusive	70-1176-COM0246	FDA UDI	Class I	Active
Inclusive	70-1135-CAM0060	FDA UDI	Class I	Active
Inclusive	70-1048-COM0196	FDA UDI	Class I	Active
Glidewell HT™	70-1190-IMP0007	FDA UDI	Class II	Active
ACE Surgical	2010451	FDA UDI	Class I	Active
Inclusive®	70-1178-COM0007	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0017	FDA UDI	Class I	Active
Inclusive	70-1051-COM0125	FDA UDI	Class I	Active
BruxZir®	70-1182-BZE0550	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0156	FDA UDI	Class II	Active
Inclusive	70-1176-COM0207	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0067	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0136	FDA UDI	Class II	Unknown
BruxZir®	70-1185-NOW0084	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0055	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0132	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0228	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0127	FDA UDI	Class II	Unknown
Hahn	70-1153-IMP0007	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0062	FDA UDI	Class II	Unknown
Inclusive	70-1052-COM0103	FDA UDI	Class I	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0262	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0016	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0445	FDA UDI	Class I	Active
Inclusive	70-1051-COM0111	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0320	FDA UDI	Class II	Unknown
Hahn	70-1174-SRG0022	FDA UDI	Class I	Active
Hahn	70-1071-SRG0184	FDA UDI	Class I	Active
Glidewell HT™	70-1189-IMP0016	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0133	FDA UDI	Class II	Active
Silent Nite Sleep Appliance with Glidewell Hinge	SNGLHGHU	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0640	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0089	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0009	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0118	FDA UDI	Class II	Active
Obsidian	70-1124-PUS0023	FDA UDI	Class II	Unknown
Hahn	70-1153-PRA0067	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.