FDA.reportPublic FDA data

510(k) K223816

Device
Dental CT Scanner AXR
Applicant
Alliage S/A Industrias Medico Odontológica
510(k) number
K223816
Product code
OAS
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-07
Date received
2022-12-20
Regulation
892.1750
Classification name
X-Ray, Tomography, Computed, Dental
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Abbreviated
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Daniel Camargo
Address
Rod. Abrão Assed, Km 53+450m Recreio Anhanguera BR 14097-500 14097-500

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OAS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.2026-06-04
K253935medXion NEXUSmedXion Technologies, Inc.2026-05-15
K260462RCT800Ray Co., Ltd.2026-04-09
K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.2026-03-31
K252353myray ProXIma X6Cefla S.C.2026-03-10
K253959Primevision 3DDentsply Sirona2026-02-05
K251798RCT700Ray Co., Ltd.2025-11-25
K251842Dental Computed Tomography X-ray SystemFussen Technology Co., Ltd.2025-11-13
K250060GT300; GT300-CGenoray Co., Ltd.2025-10-08
K251642Dental CBCT X-ray SystemYian Medical Technology (Haining) Co., Ltd.2025-06-27
K243337Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.2025-04-17
K243903RCT600Ray Co., Ltd.2025-03-12
K243088Green X 12 SE (PHT-40CHS)VATECH Co., Ltd.2025-02-21
K243081Green X 21 (PHT-90CHO)VATECH Co., Ltd.2025-02-14
K242805Dental Cone-beam Computed Tomography (FinScan F350)Changzhou Finno Medical Technology Co., Ltd.2025-01-09