Accurator AL2080
by Beyes Dental Canada Inc 2 variants
Accurator AL2080 (Accurator A2) is a device classified as Unclassified made by Beyes Dental Canada Inc, cleared under FDA 510(k) K181087 on 18 Dec 2018 and listed in FDA GUDID since 10 May 2023 (UDI-DI 00990010301221), 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 | Number00990010301221 | Date10 May 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK181087 | Date18 Dec 2018 | StatusActive |
Official records
- AccessGUDID record 00990010301221
- FDA 510(k) database K181087
Across registries
- FDA 510(k) K181087 decided 18 Dec 2018 Active
- FDA GUDID UDI-DI 00990010301221 listed 10 May 2023 Listed
Timeline
- Cleared FDA 510(k) K181087
- Listed FDA GUDID 00990010301221
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Accurator
- Generic name
- Endodontic apex locator
- Model / Ref / Catalog
- AL2080, Accurator A2
- Primary DI / UDI-DI
- 00990010301221
- 510(k) Number
- FDA product code
- LQY
- GMDN term
- Endodontic apex locator
- Device class
- U
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
Similar devices in this category
Other devices filed under Endodontic apex locator.