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 2 of 112

Device	Model / Reference	Registries	Class	Status
Inclusive	70-1071-SRG0012	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0654	FDA UDI	Class II	Active
Inclusive	70-1051-COM0274	FDA UDI	Class II	Active
Inclusive®	70-1052-COM0153	FDA UDI	Class II	Active
BruxZir	70-1185-BXP0580	FDA UDI	Class II	Active
Inclusive	70-1051-COM0237	FDA UDI	Class I	Active
BruxZir	70-1167-NOW0027	FDA UDI	Class II	Unknown
Inclusive	70-1176-COM0247	FDA UDI	Class I	Active
Inclusive	70-1054-COM0097	FDA UDI	Class I	Active
BruxZir	70-1160-BXA0003	FDA UDI	Class II	Active
Glidewell IH™	70-1071-SRG0422	FDA UDI	Class I	Active
Inclusive®	70-1055-COM0067	FDA UDI	Class I	Active
Inclusive	70-1054-COM0100	FDA UDI	Class I	Active
Glidewell™ 3DP Denture Teeth Resin Shade C4	70-1164-GBD0007	FDA UDI	Class II	Active
ACE Surgical	3010431	FDA UDI	Class I	Active
BruxZir	70-1158-BXA0024	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0093	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0010	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0578	FDA UDI	Class II	Active
BruxZir®	70-1182-BZE0064	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0219	FDA UDI	Class II	Active
Inclusive®	70-1071-SRG0385	FDA UDI	Class I	Active
BruxZir Shaded 16 PLUS	70-1186-BXP0025	FDA UDI	Class II	Unknown
Inclusive	70-1173-COM0053	FDA UDI	Class I	Active
Inclusive	70-1049-COM0041	FDA UDI	Class I	Active
Inclusive	70-1147-COM0033	FDA UDI	Class II	Active
Inclusive	70-1048-COM0213	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0111	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0030	FDA UDI	Class II	Active
BruxZir	70-1010-BRX0180	FDA UDI	Class II	Active
BruxZir	70-1138-BSA0677	FDA UDI	Class II	Unknown
Inclusive	70-1054-COM0075	FDA UDI	Class II	Active
Inclusive®	70-1172-COM0033	FDA UDI	Class I	Active
BruxZir	70-1138-BSA0624	FDA UDI	Class II	Active
BruxZir	70-1155-BXA0015	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRA0053	FDA UDI	Class II	Active
Glidewell HT™	70-1190-PRC0040	FDA UDI	Class I	Active
BruxZir®	70-1185-NOW0085	FDA UDI	Class II	Active
Inclusive	70-1050-COM0075	FDA UDI	Class II	Active
BruxZir Shaded 16 PLUS	70-1185-BXP0059	FDA UDI	Class II	Active
Inclusive	70-1051-COM0215	FDA UDI	Class I	Active
Inclusive	70-1051-COM0207	FDA UDI	Class I	Active
Hahn	70-1154-IMP0017	FDA UDI	Class II	Active
BruxZir	70-1160-BXA0030	FDA UDI	Class II	Active
BruxZir®	70-1185-NOW0124	FDA UDI	Class II	Active
Glidewell HT™	70-1071-SRG0345	FDA UDI	Class I	Active
Glidewell HT™	70-1071-SRG0264	FDA UDI	Class I	Active
BruxZir Esthetic	70-1183-BEP0003	FDA UDI	Class II	Unknown
BruxZir Shaded 16 PLUS	70-1185-BXP0132	FDA UDI	Class II	Active
Inclusive	70-1066-MNP0004	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.