EdgePRO™ 4200218
EdgePRO™ 4200218 is a Class II device made by US Endodontics, LLC., cleared under FDA 510(k) K213428 on 22 Dec 2021 and listed in FDA GUDID since 25 Jun 2023 (UDI-DI 00818365026654), 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 | Number00818365026654 | Date25 Jun 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213428 | Date22 Dec 2021 | StatusActive |
Official records
- AccessGUDID record 00818365026654
- FDA 510(k) database K213428
Across registries
- FDA 510(k) K213428 decided 22 Dec 2021 Active
- FDA GUDID UDI-DI 00818365026654 listed 25 Jun 2023 Listed
Timeline
- Cleared FDA 510(k) K213428
- Listed FDA GUDID 00818365026654
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EdgePRO™
- Generic name
- Dental solid-state laser system
- Model / Ref / Catalog
- 4200218
- Primary DI / UDI-DI
- 00818365026654
- 510(k) Number
- FDA product code
- NVK
- GMDN term
- Dental solid-state laser system
- Device class
- Class II
- Regulation number
- 878.4810
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Dental solid-state laser system.