OAS — X-Ray, Tomography, Computed, Dental Class II
FDA product code OAS covers "X-Ray, Tomography, Computed, Dental", a Class II medical device regulated under 21 CFR 892.1750. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OAS
- Device Class
- Class II
- Regulation Number
- 892.1750
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K250839 | changzhou boen zhongding medical technology co | Dental X-ray System | June 11, 2026 |
| K260662 | yofo medical technology co | Dental Cone Beam Computed Tomography System | June 4, 2026 |
| K253935 | medxion technologies | medXion NEXUS | May 15, 2026 |
| K260462 | ray co | RCT800 | April 9, 2026 |
| K260093 | vatech co | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | March 31, 2026 |
| K252353 | cefla s.c | myray ProXIma X6 | March 10, 2026 |
| K253959 | dentsply sirona | Primevision 3D | February 5, 2026 |
| K251798 | ray co | RCT700 | November 25, 2025 |
| K251842 | fussen technology co | Dental Computed Tomography X-ray System | November 13, 2025 |
| K250060 | genoray co | GT300; GT300-C | October 8, 2025 |
| K251642 | yian medical technology (haining) co | Dental CBCT X-ray System | June 27, 2025 |
| K243337 | yofo medical technology co | Dental Cone Beam Computed Tomography System | April 17, 2025 |
| K243903 | ray co | RCT600 | March 12, 2025 |
| K243088 | vatech co | Green X 12 SE (PHT-40CHS) | February 21, 2025 |
| K243081 | vatech co | Green X 21 (PHT-90CHO) | February 14, 2025 |
| K242805 | changzhou finno medical technology co | Dental Cone-beam Computed Tomography (FinScan F350) | January 9, 2025 |
| K241249 | palodex group | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | September 12, 2024 |
| K233806 | osstem implant co | T2 Plus | September 6, 2024 |
| K240855 | yian medical technology (haining) co | Dental Cone-beam Computed Tomography | April 25, 2024 |
| K232710 | yian medical technology (haining) co | Dental Cone-beam Computed Tomography | January 9, 2024 |