K213282 is an FDA 510(k) clearance for the ERI Handheld Dental X-ray System (Model AG100). This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).
Submitted by Energy Resources International Co., Ltd. Hsinchu Branch (Zhubei City, TW). The FDA issued a Cleared decision on April 4, 2022, 185 days after receiving the submission on October 1, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K213282 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2021 |
| Decision Date | April 04, 2022 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |