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 10 of 112

Device	Model / Reference	Registries	Class	Status
Camouflage	70-1151-CMU0016	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0962	FDA UDI	Class II	Active
Inclusive	70-1048-COM0178	FDA UDI	Class I	Unknown
Glidewell HT™	70-1190-PRC0001	FDA UDI	Class I	Active
Inclusive	70-1147-COM0096	FDA UDI	Class II	Active
Inclusive	70-1174-SRG0017	FDA UDI	Class I	Active
Inclusive®	70-1172-COM0061	FDA UDI	Class I	Active
Inclusive	70-1047-COM0118	FDA UDI	Class I	Active
BruxZir	70-1119-BXS0079	FDA UDI	Class II	Active
Inclusive	70-1051-COM0205	FDA UDI	Class I	Active
Inclusive	70-1051-COM0096	FDA UDI	Class II	Active
BruxZir	70-1117-BXS0049	FDA UDI	Class II	Active
BruxZir	70-1119-BXS0083	FDA UDI	Class II	Active
Inclusive	70-1047-COM0152	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0018	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0169	FDA UDI	Class II	Active
Inclusive	70-1052-COM0066	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0723	FDA UDI	Class II	Active
fastdesign.io	70-1181-MIL0016	FDA UDI	Class II	Active
Hahn	70-1071-SRG0231	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0109	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0398	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0019	FDA UDI	Class I	Active
Inclusive	70-1072-PRC0009	FDA UDI	Class I	Active
Glidewell IH™	70-1073-PRA0113	FDA UDI	Class II	Active
Inclusive	70-1047-COM0099	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0249	FDA UDI	Class II	Active
Inclusive	70-1051-COM0154	FDA UDI	Class II	Active
Inclusive	70-1073-PRA0036	FDA UDI	Class I	Active
Obsidian	70-1121-OBP0136	FDA UDI	Class II	Active
Inclusive	70-1048-COM0198	FDA UDI	Class I	Active
Glidewell™ 3DP Denture Teeth Resin Shade BL1	70-1164-GBD0011	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0030	FDA UDI	Class I	Active
Glidewell HT™	70-1190-PRC0021	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0075	FDA UDI	Class II	Unknown
Inclusive	70-1174-SRG0013	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0060	FDA UDI	Class II	Unknown
BruxZir Esthetic	70-1183-BEP0041	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0136	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0356	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0308	FDA UDI	Class II	Unknown
Inclusive	70-1069-IMP0018	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0082	FDA UDI	Class II	Active
Obsidian	70-1121-OBP0098	FDA UDI	Class II	Unknown
BruxZir	70-1159-BXA0031	FDA UDI	Class II	Active
BruxZir NOW	70-1182-NOW0024	FDA UDI	Class II	Active
Inclusive®	70-1190-COM0111	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0160	FDA UDI	Class II	Active
Inclusive	70-1074-PRS0002	FDA UDI	Class II	Active
Inclusive	70-1071-SRG0161	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.