Skip to content

Compex HD

by Addent, Inc.

510(k) K182017

Compex HD is a Class I device made by Addent, Inc., cleared under FDA 510(k) K182017 on 29 Apr 2019, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182017 Date29 Apr 2019ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QGO
Device class
Class I
Regulation
21 CFR Part 872.6100
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K182017

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K182017
UDI-DISize and differences
AdDent Compex HD
Addent, Inc.
130000 / Compex HDD8691300001 —On the market

Other devices from Addent, Inc.

  • AdDent Compex HD

    Class I

  • AdDent OraBlu

    Class II

  • AdDent Microlux

    Class II

  • AdDent Calset

    Class I

See all devices from Addent, Inc. →