EndoPilot Komet comfort
EndoPilot Komet comfort (110 0607) is a device classified as Unclassified made by Schlumbohm GmbH & Co. KG, cleared under FDA 510(k) K202906 on 13 Apr 2021 and listed in FDA GUDID since 25 May 2021 (UDI-DI 04260482991029), 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 | Number04260482991029 | Date25 May 2021 | StatusListed |
| United States | FDA 510(k) | NumberK202906 | Date13 Apr 2021 | StatusActive |
Official records
- AccessGUDID record 04260482991029
- FDA 510(k) database K202906
Across registries
- FDA 510(k) K202906 decided 13 Apr 2021 Active
- FDA GUDID UDI-DI 04260482991029 listed 25 May 2021 Listed
Timeline
- Cleared FDA 510(k) K202906
- Listed FDA GUDID 04260482991029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- EndoPilot Komet
- Generic name
- Endodontic apex locator
- Model / Ref / Catalog
- comfort, 110 0607
- Primary DI / UDI-DI
- 04260482991029
- 510(k) Number
- FDA product code
- LQY, EKX
- GMDN term
- Endodontic apex locator
- Device class
- U
- Regulation number
- 872.4200
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code LQY (Locator, Root Apex).
- APEX DAL ELECTRONIC APEX LOCATOR by Medicnrg, Ltd.
- APEX LOCATOR BINGO-1020 by Dent Corp. Research & Development
- DETECT by Forum Engineering Technologies, Ltd.
- APEXNRG RIDER by Medicnrg, Ltd.
- RAYPEX 6 by Dentsply International
- Aseptico Endopex V, Model AEU-40 by ASEPTICO, INC.
- X-Smart Pro 6779008 by SIRONA Dental Systems GmbH
- J. MORITA MFG. CORP. TR-ZX2 Type PLUS by J.MORITA MFG.CORP.
- NAVI ROOT by S-Denti Co., Ltd.
- I-ROOT by S-Denti Co., Ltd.