Osada Endex Em-S2
Osada Endex Em-S2 (5032) is a device classified as Unclassified made by Osada Electric Co., Ltd., cleared under FDA 510(k) K904742 on 17 Dec 1990 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 04580406860348), 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 | Number04580406860348 | Date20 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK904742 | Date17 Dec 1990 | StatusActive |
Official records
- AccessGUDID record 04580406860348
- FDA 510(k) database K904742
Across registries
- FDA 510(k) K904742 decided 17 Dec 1990 Active
- FDA GUDID UDI-DI 04580406860348 listed 20 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K904742
- Listed FDA GUDID 04580406860348
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Osada Endex
- Generic name
- Endodontic apex locator
- Model / Ref / Catalog
- EM-S2, 5032
- Primary DI / UDI-DI
- 04580406860348
- 510(k) Number
- FDA product code
- LQY
- GMDN term
- Endodontic apex locator
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Endodontic apex locator.