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LuxCreo Dental Clear Aligner Resin

FDA UDI

Class I (US FDA UDI)

by LuxCreo, Inc.

Identity

Trade Name
LuxCreo Dental Clear Aligner Resin FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
LuxCreo Dental Clear Aligner Resin is a liquid light-curing resin product indicated for the three-dimensional fabrication of orthodontic and dental appliances such as aligners and retainers. FDA UDI
Model / Reference
1kg/Bottle FDA UDI
Description
LuxCreo Dental Clear Aligner Resin is a liquid light-curing resin product indicated for the three-dimensional fabrication of orthodontic and dental appliances such as aligners and retainers. FDA UDI

Identifiers

Primary DI / UDI-DI
00860010425459 FDA UDI
FDA Product Code
DYT FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5525 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

LuxCreo Dental Clear Aligner Resin by LuxCreo, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LuxCreo, Inc.

Sources (1)

  • FDA UDI 5fe1305c-e79d-4122-81d8-c7af4a5f4802 34 fields · synced May 31, 2026