EndoPilot D-Pack v03
EndoPilot D-Pack v03 (109 0151) is a Class I device made by Schlumbohm GmbH & Co. KG, cleared under FDA 510(k) K202906 on 13 Apr 2021 and listed in FDA GUDID since 10 Sep 2021 (UDI-DI 04260482990190), 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 | Number04260482990190 | Date10 Sep 2021 | StatusListed |
| United States | FDA 510(k) | NumberK202906 | Date13 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 04260482990190
- FDA 510(k) database K202906
Across registries
- FDA 510(k) K202906 decided 13 Apr 2021 Active
- FDA GUDID UDI-DI 04260482990190 listed 10 Sep 2021 Listed
Timeline
- Cleared FDA 510(k) K202906
- Listed FDA GUDID 04260482990190
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EndoPilot D-Pack
- Generic name
- Endodontic obturation system
- Model / Ref / Catalog
- v03, 109 0151
- Primary DI / UDI-DI
- 04260482990190
- 510(k) Number
- FDA product code
- EKR
- GMDN term
- Endodontic obturation system
- Device class
- Class I
- Regulation number
- 872.4565
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Endodontic obturation system.