Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OAS — Predicate Candidate Screening
135 FDA 510(k) clearances under this product code; the 50 most recent screened below.
113 daysmedian FDA review time
268 days90th percentile
135clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 | 56 | 0 |
| K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026-06-11 | 448 | 0 |
| K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2026-06-04 | 94 | 0 |
| K253935 | medXion NEXUS | medXion Technologies, Inc. | 2026-05-15 | 157 | 0 |
| K260462 | RCT800 | Ray Co., Ltd. | 2026-04-09 | 56 | 0 |
| K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | 2026-03-31 | 77 | 0 |
| K252353 | myray ProXIma X6 | Cefla S.C. | 2026-03-10 | 224 | 0 |
| K253959 | Primevision 3D | Dentsply Sirona | 2026-02-05 | 57 | 0 |
| K251798 | RCT700 | Ray Co., Ltd. | 2025-11-25 | 166 | 0 |
| K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd. | 2025-11-13 | 150 | 0 |
| K250060 | GT300; GT300-C | Genoray Co., Ltd. | 2025-10-08 | 271 | 0 |
| K251642 | Dental CBCT X-ray System | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 | 29 | 0 |
| K243337 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | 2025-04-17 | 174 | 0 |
| K243903 | RCT600 | Ray Co., Ltd. | 2025-03-12 | 83 | 0 |
| K243088 | Green X 12 SE (PHT-40CHS) | VATECH Co., Ltd. | 2025-02-21 | 144 | 0 |
| K243081 | Green X 21 (PHT-90CHO) | VATECH Co., Ltd. | 2025-02-14 | 137 | 0 |
| K242805 | Dental Cone-beam Computed Tomography (FinScan F350) | Changzhou Finno Medical Technology Co., Ltd. | 2025-01-09 | 114 | 0 |
| K241249 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP | Palodex Group OY | 2024-09-12 | 132 | 0 |
| K233806 | T2 Plus | Osstem Implant Co., Ltd. | 2024-09-06 | 282 | 1 |
| K240855 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-04-25 | 28 | 0 |
| K232710 | Dental Cone-beam Computed Tomography | Yian Medical Technology (Haining) Co., Ltd. | 2024-01-09 | 126 | 0 |
| K230985 | Planmeca Viso | Planmeca Oy | 2023-12-28 | 266 | 0 |
| K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | 2023-12-14 | 232 | 0 |
| K232487 | Provecta 3D Prime and Provecta 3D Prime Ceph | Durr Dental SE | 2023-09-14 | 28 | 0 |
| K232166 | PreXion3D Expedition | Prexion Corporation | 2023-09-08 | 49 | 0 |
| K232287 | RAYSCAN a-Expert3D | Ray Co., Ltd. | 2023-08-31 | 30 | 0 |
| K231796 | Grreen X 12 (Model: PHT-75CHS) | VATECH Co., Ltd. | 2023-07-19 | 29 | 0 |
| K222666 | X-View 3D Pan/X-View 2D Pan | Trident S.R.L | 2023-07-10 | 307 | 0 |
| K230505 | Orthopantomograph™ OP 3D LX | Palodex Group OY | 2023-06-09 | 105 | 0 |
| K230753 | RCT800 | Ray Co., Ltd. | 2023-04-11 | 25 | 0 |
| K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontológica | 2023-04-07 | 108 | 0 |
| K223794 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2023-01-17 | 29 | 0 |
| K222150 | PreXion3D Expedition | Prexion Corporation | 2023-01-12 | 176 | 0 |
| K222219 | R2 Studio Q/RCT820 | Megagen Implant Co., Ltd. | 2022-12-06 | 134 | 0 |
| K221525 | PreXion3D Explorer PRO | Prexion Corporation | 2022-07-22 | 57 | 0 |
| K220392 | PAPAYA 3D & PAPAYA 3D Plus | Genoray Co., Ltd. | 2022-05-19 | 97 | 0 |
| K213278 | Planmed Verity | Planmed OY | 2022-04-28 | 209 | 0 |
| K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris | Fona S.R.L | 2022-03-02 | 112 | 0 |
| K214084 | hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS | Cefla S.C. | 2022-01-20 | 24 | 0 |
| K211159 | eco-x Series (eco-x, eco-x-s) | Hdx Will Corp. | 2021-12-30 | 255 | 0 |
| K213226 | RCT700 | Ray Co., Ltd. | 2021-11-29 | 61 | 0 |
| K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Hdx Will Corp. | 2021-10-19 | 92 | 0 |
| K212303 | T2 | Osstem Implant Co., Ltd. | 2021-09-21 | 60 | 1 |
| K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica | 2021-08-10 | 144 | 0 |
| K200270 | rainbow MCT | Dentium Co., Ltd (Ict Branch) | 2021-04-16 | 437 | 0 |
| K200271 | rainbow CT | Dentium Co., Ltd (Ict Branch) | 2021-04-16 | 437 | 0 |
| K203784 | PreXion3D Explorer PRO | Prexion Corporation | 2021-02-23 | 57 | 0 |
| K210329 | Green X 18(Model : PHT-75CHS) | VATECH Co., Ltd. | 2021-02-18 | 14 | 0 |
| K201378 | 3D Accuitomo 150N | J. Morita USA, Inc. | 2021-02-18 | 268 | 0 |
| K203797 | vatech A9 (Model : PHT-30CSS) | VATECH Co., Ltd. | 2021-01-25 | 28 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda