X-Ray, Tomography, Computed, Dental
Regulation 892.1750
11510(k)s in 12 months (136 all time)
3recalls in 12 months (7 all time)
7recalls that name a 510(k)
Top companies in OAS
| Company | 510(k)s | Recalls |
|---|---|---|
| VATECH Co., Ltd. | 19 | 0 |
| Ray Co., Ltd. | 15 | 0 |
| Palodex Group OY | 8 | 1 |
| Prexion Corporation | 9 | 0 |
| Cefla S.C. | 7 | 0 |
| Osstem Implant Co., Ltd. | 3 | 3 |
| Trophy | 4 | 1 |
| Genoray Co., Ltd. | 4 | 0 |
| Dentium Co., Ltd (Ict Branch) | 3 | 0 |
| Dentsply Sirona | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2026 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) Fussen Technology Co., Ltd., CN | OAS |
| Jul 23, 2026 | K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) Hefei Meyer Optoelectronic Technology, Inc., CN | OAS |
| Jun 11, 2026 | K250839 | Dental X-ray System Changzhou Boen Zhongding Medical Technology Co., Ltd., CN | OAS |
| Jun 4, 2026 | K260662 | Dental Cone Beam Computed Tomography System Yofo Medical Technology Co., Ltd., CN | OAS |
| May 15, 2026 | K253935 | medXion NEXUS medXion Technologies, Inc., JP | OAS |
| Apr 9, 2026 | K260462 | RCT800 Ray Co., Ltd., KR | OAS |
| Mar 31, 2026 | K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) VATECH Co., Ltd., KR | OAS |
| Mar 10, 2026 | K252353 | myray ProXIma X6 Cefla S.C., IT | OAS |
| Feb 5, 2026 | K253959 | Primevision 3D Dentsply Sirona | OAS |
| Nov 25, 2025 | K251798 | RCT700 Ray Co., Ltd., KR | OAS |
| Nov 13, 2025 | K251842 | Dental Computed Tomography X-ray System Fussen Technology Co., Ltd., CN | OAS |
| Oct 8, 2025 | K250060 | GT300; GT300-C Genoray Co., Ltd., KR | OAS |
| Jun 27, 2025 | K251642 | Dental CBCT X-ray System Yian Medical Technology (Haining) Co., Ltd., CN | OAS |
| Apr 17, 2025 | K243337 | Dental Cone Beam Computed Tomography System Yofo Medical Technology Co., Ltd., CN | OAS |
| Mar 12, 2025 | K243903 | RCT600 Ray Co., Ltd., KR | OAS |
| Feb 21, 2025 | K243088 | Green X 12 SE (PHT-40CHS) VATECH Co., Ltd., KR | OAS |
| Feb 14, 2025 | K243081 | Green X 21 (PHT-90CHO) VATECH Co., Ltd., KR | OAS |
| Jan 9, 2025 | K242805 | Dental Cone-beam Computed Tomography (FinScan F350) Changzhou Finno Medical Technology Co., Ltd., CN | OAS |
| Sep 12, 2024 | K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) Palodex Group OY, FI | OAS |
| Sep 6, 2024 | K233806 | T2 Plus Osstem Implant Co., Ltd., KR | OAS |
| Apr 25, 2024 | K240855 | Dental Cone-beam Computed Tomography Yian Medical Technology (Haining) Co., Ltd., CN | OAS |
| Jan 9, 2024 | K232710 | Dental Cone-beam Computed Tomography Yian Medical Technology (Haining) Co., Ltd., CN | OAS |
| Dec 28, 2023 | K230985 | Planmeca Viso Planmeca Oy, FI | OAS |
| Dec 14, 2023 | K231181 | bright CT Dentium Co., Ltd (Ict Branch), KR | OAS |
| Sep 14, 2023 | K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph Durr Dental SE, DE | OAS |
| Sep 8, 2023 | K232166 | PreXion3D Expedition Prexion Corporation, JP | OAS |
| Aug 31, 2023 | K232287 | RAYSCAN a-Expert3D Ray Co., Ltd., KR | OAS |
| Jul 19, 2023 | K231796 | Grreen X 12 (Model: PHT-75CHS) VATECH Co., Ltd., KR | OAS |
| Jul 10, 2023 | K222666 | X-View 3D Pan/X-View 2D Pan Trident S.R.L, IT | OAS |
| Jun 9, 2023 | K230505 | Orthopantomograph OP 3D LX Palodex Group OY, FI | OAS |
| Apr 11, 2023 | K230753 | RCT800 Ray Co., Ltd., KR | OAS |
| Apr 7, 2023 | K223816 | Dental CT Scanner AXR Alliage S/A Industrias Medico Odontológica, BR | OAS |
| Jan 17, 2023 | K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Cefla S.C., IT | OAS |
| Jan 12, 2023 | K222150 | PreXion3D Expedition Prexion Corporation, JP | OAS |
| Dec 6, 2022 | K222219 | R2 Studio Q/RCT820 Megagen Implant Co., Ltd., KR | OAS |
| Jul 22, 2022 | K221525 | PreXion3D Explorer PRO Prexion Corporation, JP | OAS |
| May 19, 2022 | K220392 | PAPAYA 3D & PAPAYA 3D Plus Genoray Co., Ltd., KR | OAS |
| Apr 28, 2022 | K213278 | Planmed Verity Planmed OY, FI | OAS |
| Mar 2, 2022 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph Fona S.R.L, IT | OAS |
| Jan 20, 2022 | K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Cefla S.C., IT | OAS |
| Dec 30, 2021 | K211159 | eco-x Series (eco-x, eco-x-s) Hdx Will Corp., KR | OAS |
| Nov 29, 2021 | K213226 | RCT700 Ray Co., Ltd., KR | OAS |
| Oct 19, 2021 | K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) Hdx Will Corp., KR | OAS |
| Sep 21, 2021 | K212303 | T2 Osstem Implant Co., Ltd., KR | OAS |
| Aug 10, 2021 | K210820 | EAGLE EDGE AXR90 and AXR120 Alliage S/A Industrias Medico Odontológica, BR | OAS |
| Apr 16, 2021 | K200271 | rainbow CT Dentium Co., Ltd (Ict Branch), KR | OAS |
| Apr 16, 2021 | K200270 | rainbow MCT Dentium Co., Ltd (Ict Branch), KR | OAS |
| Feb 23, 2021 | K203784 | PreXion3D Explorer PRO Prexion Corporation, JP | OAS |
| Feb 18, 2021 | K210329 | Green X 18(Model : PHT-75CHS) VATECH Co., Ltd., KR | OAS |
| Feb 18, 2021 | K201378 | 3D Accuitomo 150N J. Morita USA, Inc. | OAS |
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