PRO Resins Arch X 019.3259
PRO Resins Arch X 019.3259 is a Class II device made by DeltaMed GmbH, cleared under FDA 510(k) K243720 on 18 Dec 2024 and listed in FDA GUDID since 14 Feb 2025 (UDI-DI 04260635981518), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04260635981518 | Date14 Feb 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243720 | Date18 Dec 2024 | StatusActive |
Official records
- AccessGUDID record 04260635981518
- FDA 510(k) database K243720
Across registries
- FDA 510(k) K243720 decided 18 Dec 2024 Active
- FDA GUDID UDI-DI 04260635981518 listed 14 Feb 2025 Listed
Timeline
- Cleared FDA 510(k) K243720
- Listed FDA GUDID 04260635981518
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PRO Resins Arch X
- Generic name
- Dental appliance fabrication material, combination-material
- Model / Ref / Catalog
- 019.3259
- Primary DI / UDI-DI
- 04260635981518
- 510(k) Number
- FDA product code
- EBF, EBI, EBG, PZY
- GMDN term
- Dental appliance fabrication material, combination-material
- Device class
- Class II
- Regulation number
- 872.3690, 872.3760, 872.3770, 872.3590
- GUDID distribution status
- In Commercial Distribution