Is this your brand? Sign in to claim ownership.

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 78 of 112

Device	Model / Reference	Registries	Class	Status
BruxZir	70-1138-BSA0312	FDA UDI	Class II	Active
Inclusive	70-1176-COM0232	FDA UDI	Class II	Active
CAMouflage	70-1000-CMN0041	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0140	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0655	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0059	FDA UDI	Class II	Unknown
BruxZir	70-1157-BXA0033	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0019	FDA UDI	Class II	Active
Inclusive	70-1054-COM0161	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0318	FDA UDI	Class II	Unknown
Inclusive	70-1053-COM0041	FDA UDI	Class I	Unknown
BruxZir®	70-1185-NOW0080	FDA UDI	Class II	Active
Inclusive	70-1053-COM0050	FDA UDI	Class I	Active
Inclusive	70-1050-COM0099	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0240	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0378	FDA UDI	Class I	Active
CAMouflage	70-1000-CMN0023	FDA UDI	Class II	Active
Inclusive	70-1153-PRA0030	FDA UDI	Class I	Unknown
Hahn	70-1153-PRA0111	FDA UDI	Class I	Active
Inclusive	70-1176-COM0202	FDA UDI	Class II	Active
Inclusive	70-1176-COM0300	FDA UDI	Class I	Active
Inclusive	70-1047-COM0084	FDA UDI	Class II	Active
Glidewell IH™	70-1073-PRA0131	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0018	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0005	FDA UDI	Class II	Active
Inclusive	70-1173-COM0056	FDA UDI	Class II	Active
Inclusive	70-1051-COM0174	FDA UDI	Class II	Active
Inclusive	70-1049-COM0061	FDA UDI	Class II	Active
BruxZir	4400168	FDA UDI	Class II	Active
Glidewell RMGI Cement	70-1198-PVC0001	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0066	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0335	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0352	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0014	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0176	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0193	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0664	FDA UDI	Class II	Active
Silent Nite Sleep Appliance with Glidewell Hinge	SNGLHGXPHU	FDA UDI	Class II	Active
Inclusive	70-1068-IMP0007	FDA UDI	Class II	Active
Inclusive®	70-1168-COM0028	FDA UDI	Class I	Active
Hahn	70-1154-IMP0008	FDA UDI	Class II	Active
BruxZir	70-1118-BXS0117	FDA UDI	Class II	Active
Inclusive	70-1052-COM0104	FDA UDI	Class I	Unknown
BruxZir Shaded 16 PLUS	70-1186-BXP0118	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0263	FDA UDI	Class II	Active
Inclusive	70-1048-COM0203	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0061	FDA UDI	Class I	Active
Inclusive®	70-1056-COM0025	FDA UDI	Class I	Active
Inclusive	70-1050-COM0001	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0321	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.