Skip to content

A-dec 345

by A-Dec, Inc.

A-dec 345 is a Class I device made by A-Dec, Inc., cleared under FDA 510(k) K082985 on 17 Dec 2008 and listed in FDA GUDID since 17 Feb 2026 (UDI-DI 10194665008697), 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) K082985

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 Number10194665008697 UDI-DI Date17 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK082985 Date17 Dec 2008DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K082985 decided 17 Dec 2008 Active
  • FDA GUDID UDI-DI 10194665008697 listed 17 Feb 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K082985
  2. Listed FDA GUDID 10194665008697

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
A-dec
Generic name
Dental delivery system
Model / Ref / Catalog
345
Primary DI / UDI-DI
10194665008697
510(k) Number
FDA product code
EIA
GMDN term
Dental delivery system
Device class
Class I
Regulation number
872.6640
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K082985)

and 8 more cleared under K082985

Similar devices

Other devices filed under FDA product code EIA (Unit, Operative Dental).

Other devices from A-Dec, Inc.

  • A-dec 54.1073.00

    Class I

  • A-dec 54.0924.01

    Class I

  • A-dec 54.1074.01

    Class I

  • A-dec 54.1073.01

    Class I

See all devices from A-Dec, Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)