ScanX Edge G8300
ScanX Edge G8300 is a Class II device made by Durr Dental AG, cleared under FDA 510(k) K170733 on 1 May 2017 and listed in FDA GUDID since 9 Mar 2020 (UDI-DI E247G8300), active as of 22 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 | NumberE247G8300 | Date9 Mar 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170733 | Date1 May 2017 | StatusActive |
Official records
- FDA 510(k) database K170733
Across registries
- FDA 510(k) K170733 decided 1 May 2017 Active
- FDA GUDID UDI-DI E247G8300 listed 9 Mar 2020 Listed
Timeline
- Cleared FDA 510(k) K170733
- Listed FDA GUDID E247G8300
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ScanX Edge
- Generic name
- Dental computed radiography digital imaging scanner
- Model / reference
- G8300
- Primary DI / UDI-DI
- E247G8300
- 510(k) Number
- FDA product code
- MUH
- GMDN term
- Dental computed radiography digital imaging scanner
- Device class
- Class II
- Regulation number
- 872.1800
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental computed radiography digital imaging scanner.