T2
FDA 510(k) clearance K212303 · decided 2021-09-21
Clearance details
- K-number
- K212303
- Device name
- T2
- Applicant
- Osstem Implant Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-07-23
- Decision date
- 2021-09-21
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OAS
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Siheung-Si, KR
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osstem Implant Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Dental Cone-beam Computed Tomography (mDX-15P Series) (K261748) | Hefei Meyer Optoelectronic Technology, Inc. | 2026-07-23 |
| Dental X-ray System (K250839) | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026-06-11 |
| Dental Cone Beam Computed Tomography System (K260662) | Yofo Medical Technology Co., Ltd. | 2026-06-04 |
| medXion NEXUS (K253935) | medXion Technologies, Inc. | 2026-05-15 |
| RCT800 (K260462) | Ray Co., Ltd. | 2026-04-09 |
| Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) (K260093) | VATECH Co., Ltd. | 2026-03-31 |
| myray ProXIma X6 (K252353) | Cefla S.C. | 2026-03-10 |
| Primevision 3D (K253959) | Dentsply Sirona | 2026-02-05 |
| RCT700 (K251798) | Ray Co., Ltd. | 2025-11-25 |
| Dental Computed Tomography X-ray System (K251842) | Fussen Technology Co., Ltd. | 2025-11-13 |
| GT300; GT300-C (K250060) | Genoray Co., Ltd. | 2025-10-08 |
| Dental CBCT X-ray System (K251642) | Yian Medical Technology (Haining) Co., Ltd. | 2025-06-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Osstem Dental X-Ray System T2. Product Model Numbers T2-C and T2-CS. recall (Z-0314-2026) | OSSTEM Implant Co., Ltd. | 2025-11-05 |