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DentiqAir

by 3D Industrial Imaging Co., Ltd.

510(k) K183676

DentiqAir is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by 3D Industrial Imaging Co., Ltd., cleared under FDA 510(k) K183676 on 19 Dec 2019, active as of 22 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 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK183676 Date19 Dec 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  • Withdrawn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
LLZ
Device class
Class II
Regulation
21 CFR Part 892.2050
Advisory committee
Radiology
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 K183676

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 K183676
UDI-DISize and differences
DentiqAir 1.0
3D Industrial Imaging Co., Ltd.
1.008800022900072 —On the market

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from 3D Industrial Imaging Co., Ltd.

  • VARO Plan 1.0

    Class II

  • Dentiq3D 1.0

    Class II

  • DentiqAir 1.0

    Class II

  • DentiqGuide 1.0

    Class II

See all devices from 3D Industrial Imaging Co., Ltd. →