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AdDent Compex HD

by Addent, Inc.

AdDent Compex HD (130000) is a Class I device made by Addent, Inc., cleared under FDA 510(k) K182017 on 29 Apr 2019 and listed in FDA GUDID since 22 Apr 2026 (UDI-DI D8691300001), active as of 22 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 22 Oct 2026

Documents

510(k) K182017

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD8691300001 UDI-DI Date22 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK182017 Date29 Apr 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K182017 decided 29 Apr 2019 Active
  • FDA GUDID UDI-DI D8691300001 listed 22 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K182017
  2. Listed FDA GUDID D8691300001

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AdDent
Generic name
Dental material cartridge-plunging applicator, single-component
Model / Ref / Catalog
Compex HD, 130000
Primary DI / UDI-DI
D8691300001
510(k) Number
FDA product code
QGO
GMDN term
Dental material cartridge-plunging applicator, single-component
Device class
Class I
Regulation number
872.6100
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Addent, Inc.

See all devices from Addent, Inc. →

Properties

  • Sterilise before use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)