3Delta UNlimited 1613130
3Delta UNlimited 1613130 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 Mar 2025 (UDI-DI EDEL16131300), 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 | NumberEDEL16131300 | Date14 Mar 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK243720 | Date18 Dec 2024 | StatusActive |
Official records
- FDA 510(k) database K243720
Across registries
- FDA 510(k) K243720 decided 18 Dec 2024 Active
- FDA GUDID UDI-DI EDEL16131300 listed 14 Mar 2025 Listed
Timeline
- Cleared FDA 510(k) K243720
- Listed FDA GUDID EDEL16131300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- 3Delta UNlimited
- Generic name
- Dental appliance fabrication material, resin
- Model / Ref / Catalog
- 1613130
- Primary DI / UDI-DI
- EDEL16131300
- 510(k) Number
- FDA product code
- EBF, EBI, EBG, PZY
- GMDN term
- Dental appliance fabrication material, resin
- Device class
- Class II
- Regulation number
- 872.3690, 872.3760, 872.3770, 872.3590
- GUDID distribution status
- In Commercial Distribution