DCI Edge PJT1385
DCI Edge PJT1385 is a Class I device made by DCI International, LLC, cleared under FDA 510(k) K203791 on 21 Jun 2022 and listed in FDA GUDID since 11 Aug 2025 (UDI-DI 00810021437835), 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 | Number00810021437835 | Date11 Aug 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203791 | Date21 Jun 2022 | StatusActive |
Official records
- AccessGUDID record 00810021437835
- FDA 510(k) database K203791
Across registries
- FDA 510(k) K203791 decided 21 Jun 2022 Active
- FDA GUDID UDI-DI 00810021437835 listed 11 Aug 2025 Listed
Timeline
- Cleared FDA 510(k) K203791
- Listed FDA GUDID 00810021437835
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- DCI Edge
- Generic name
- Dental surgical power tool motorized handpiece/set, pneumatic
- Model / reference
- PJT1385
- Primary DI / UDI-DI
- 00810021437835
- 510(k) Number
- FDA product code
- EFB
- GMDN term
- Dental surgical power tool motorized handpiece/set, pneumatic
- Device class
- Class I
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Dental surgical power tool motorized handpiece/set, pneumatic.