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Accurator AL2080

by Beyes Dental Canada Inc 2 variants

Accurator AL2080 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 6 Oct 2022 (UDI-DI 00837699000031), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K181087

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00837699000031 UDI-DI Date6 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK181087 Date18 Dec 2018DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K181087 decided 18 Dec 2018 Active
  • FDA GUDID UDI-DI 00837699000031 listed 6 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K181087
  2. Listed FDA GUDID 00837699000031

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Accurator
Generic name
Endodontic apex locator
Model / reference
AL2080
Primary DI / UDI-DI
00837699000031
510(k) Number
FDA product code
LQY
GMDN term
Endodontic apex locator
Device class
U
GUDID distribution status
In Commercial Distribution

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Other devices filed under Endodontic apex locator.

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  • Duray 2D Ceph

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See all devices from Beyes Dental Canada Inc →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)