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CompuDent STA STA-5110

by Tricor Systems 2 variants

CompuDent STA STA-5110 is a Class II device made by Tricor Systems, cleared under FDA 510(k) K061904 on 8 Aug 2006 and listed in FDA GUDID since 26 Jan 2018 (UDI-DI 20618874000015), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K061904

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 Number20618874000015 UDI-DI Date26 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK061904 Date8 Aug 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K061904 decided 8 Aug 2006 Active
  • FDA GUDID UDI-DI 20618874000015 listed 26 Jan 2018 Listed

Recalls

1 recall · FDA

    • Terminated Z-1952-2015 FDA Class III initiated 11 Feb 2015

    Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the STA instrument.

Timeline

3 dated events

  1. Cleared FDA 510(k) K061904
  2. Recall initiated FDA recalls Z-1952-2015
  3. Listed FDA GUDID 20618874000015

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CompuDent STA
Generic name
Dental anaesthesia electronic injector
Model / reference
STA-5110
Primary DI / UDI-DI
20618874000015
510(k) Number
FDA product code
EJI
GMDN term
Dental anaesthesia electronic injector
Device class
Class II
Regulation number
872.6770
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental computer assisted anaesthesia injection unit

Cleared under the same submission (K061904)

and 7 more cleared under K061904

Similar devices

Other devices filed under FDA product code EJI (Syringe, Cartridge).

Other devices from Tricor Systems

See all devices from Tricor Systems →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)