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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 72 of 112

Device	Model / Reference	Registries	Class	Status
Glidewell HT™	70-1071-SRG0313	FDA UDI	Class I	Active
Inclusive	70-1050-COM0092	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0411	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0330	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0133	FDA UDI	Class I	Active
Inclusive	70-1051-COM0060	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0033	FDA UDI	Class I	Active
Inclusive	70-1050-COM0105	FDA UDI	Class I	Active
Hahn	70-1071-SRG0068	FDA UDI	Class I	Active
Hahn	70-1153-PRA0013	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0428	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0151	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0034	FDA UDI	Class II	Active
Inclusive	70-1050-COM0050	FDA UDI	Class II	Active
Hahn	70-1071-SRG0226	FDA UDI	Class I	Active
Hahn	70-1071-SRG0172	FDA UDI	Class I	Active
Inclusive	70-1176-COM0400	FDA UDI	Class II	Active
Hahn	70-1153-PRA0005	FDA UDI	Class II	Active
Obsidian	70-1122-SHS0097	FDA UDI	Class II	Unknown
Camouflage	70-1151-CMU0039	FDA UDI	Class II	Active
Inclusive®	70-1055-COM0084	FDA UDI	Class I	Active
BruxZir	70-1015-BRX0002	FDA UDI	Class II	Active
BruxZir®	70-1182-NOW0070	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0171	FDA UDI	Class II	Active
Inclusive	70-1176-COM0403	FDA UDI	Class II	Active
Hahn	70-1153-PRA0008	FDA UDI	Class II	Active
Hahn	70-1071-SRG0230	FDA UDI	Class I	Active
Inclusive	70-1047-COM0222	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0575	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0244	FDA UDI	Class II	Unknown
BruxZir	70-1138-BSA0472	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0700	FDA UDI	Class II	Unknown
Inclusive	70-1051-COM0058	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0045	FDA UDI	Class I	Active
Inclusive	70-1072-PRC0055	FDA UDI	Class I	Active
Inclusive	70-1051-COM0106	FDA UDI	Class II	Active
BruxZir NOW	70-1184-NOW0005	FDA UDI	Class II	Unknown
Inclusive	70-1147-COM0031	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0320	FDA UDI	Class I	Active
Inclusive	70-1052-COM0101	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0128	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0010	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0208	FDA UDI	Class I	Active
Inclusive	70-1176-COM0266	FDA UDI	Class I	Unknown
Inclusive	70-1070-IMP0027	FDA UDI	Class II	Active
Inclusive	70-1048-COM0164	FDA UDI	Class I	Active
BruxZir®	70-1184-RAD0036	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0005	FDA UDI	Class II	Active
Inclusive	70-1048-COM0100	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0095	FDA UDI	Class II	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.