File Hook(1pcs) AC0401
File Hook(1pcs) AC0401 is an endodontic apex locator (FDA unclassified; FDA product code LQY, Locator, Root Apex) made by Good Doctors Co., Ltd., cleared under FDA 510(k) K151274 on 4 Feb 2016 and listed in FDA GUDID since 23 Aug 2023 (UDI-DI 08800025400524), 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 | Number08800025400524 | Date23 Aug 2023 | StatusListed |
| United States | FDA 510(k) | NumberK151274 | Date4 Feb 2016 | StatusActive |
Official records
- AccessGUDID record 08800025400524
- FDA 510(k) database K151274
Across registries
- FDA 510(k) K151274 decided 4 Feb 2016 Active
- FDA GUDID UDI-DI 08800025400524 listed 23 Aug 2023 Listed
Timeline
- Cleared FDA 510(k) K151274
- Listed FDA GUDID 08800025400524
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- File Hook(1pcs)
- Generic name
- Endodontic apex locator
- Model / reference
- AC0401
- Primary DI / UDI-DI
- 08800025400524
- 510(k) Number
- FDA product code
- LQY
- GMDN term
- Endodontic apex locator
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
Similar devices in this category
Other devices filed under Endodontic apex locator.