Is this your brand? Sign in to claim ownership.

PRISMATIK DENTALCRAFT, INC.

Last updated September 17, 2026

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 104 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1173-COM0058	FDA UDI	Class I	Active
Inclusive®	70-1168-COM0001	FDA UDI	Class II	Active
Inclusive	70-1147-COM0029	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0047	FDA UDI	Class I	Active
Inclusive	70-1047-COM0165	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0101	FDA UDI	Class II	Active
Inclusive	70-1147-COM0046	FDA UDI	Class II	Active
BruxZir	70-1158-BXA0028	FDA UDI	Class II	Active
Inclusive	70-1147-COM0015	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0124	FDA UDI	Class II	Active
Hahn	70-1153-IMP0004	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0035	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0133	FDA UDI	Class II	Active
Glidewell IH™	70-1207-IMP0011	FDA UDI	Class II	Active
Inclusive	70-1139-COM0002	FDA UDI	Class II	Active
Inclusive	70-1050-COM0110	FDA UDI	Class I	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0031	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0270	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0053	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0116	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0944	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0591	FDA UDI	Class II	Active
Inclusive	70-1173-COM0052	FDA UDI	Class I	Unknown
BruxZir	70-1158-BXA0003	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0106	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0057	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0031	FDA UDI	Class I	Active
Inclusive®	70-1190-COM0030	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0458	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0057	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0188	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0816	FDA UDI	Class II	Active
Inclusive	70-1135-CAM0075	FDA UDI	Class I	Active
Hahn	70-1153-PRA0079	FDA UDI	Class II	Active
Inclusive	70-1072-PRC0056	FDA UDI	Class I	Active
BruxZir	70-1185-BXP0573	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0144	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0105	FDA UDI	Class II	Active
BruxZir Esthetic	70-1183-BEP0122	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0168	FDA UDI	Class II	Active
BioTemps	70-1181-MIL0094	FDA UDI	U	Active
Glidewell IH™	70-1071-SRG0439	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0209	FDA UDI	Class II	Active
Obsidian	70-1122-OMB0004	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0159	FDA UDI	Class I	Active
Inclusive®	70-1169-COM0002	FDA UDI	Class II	Active
BruxZir™ Basic Shade Coloring Liquid	70-1123-BRX0009	FDA UDI	Class II	Active
Inclusive	70-1047-COM0168	FDA UDI	Class I	Active
Hahn	70-1071-SRG0085	FDA UDI	Class I	Active
Glidewell IH™	70-1207-IMP0009	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.