Identity
- Trade Name
- LuxaPrint Ortho Flex 385 FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer trays (in case of indirect bonding of brackets) using 3D printing. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Shade: Transparent, Content: 1 Bottle @ 5 kg FDA UDI
- Model / Reference
- 171284 FDA UDI
- Description
- (Meth) acrylate-based light-curing resin for the fabrication of bleaching trays and transfer trays (in case of indirect bonding of brackets) using 3D printing. For DLP/ STL printers at a wavelength of 405 nm or 385 nm. High spirits in 3D. Shade: Transparent, Content: 1 Bottle @ 5 kg FDA UDI
Identifiers
- Catalog Number
- 171284 FDA UDI
- Primary DI / UDI-DI
- D9821712840 FDA UDI
- FDA Product Code
- QJJ FDA UDI
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.5410 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental appliance fabrication material, resin
LuxaPrint Ortho Flex 385 by DMG Digital Enterprises SE — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- DMG Digital Enterprises SE
Sources (1)
- FDA UDI 4857df51-b241-46ed-80c0-fea9c663b107 36 fields · synced May 30, 2026