EM SA Implant System — Hiossen, Inc. (510(k) K191201)
EM SA Implant System — Hiossen, Inc. (510(k) K191201) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: EM SA Implant System; Applicant: Hiossen, Inc.; Clearance track: 510(k).
| Device name | EM SA Implant System |
|---|---|
| Applicant | Hiossen, Inc. |
| Clearance track | 510(k) |
| Submission number | K191201 |
| Decision | Substantially Equivalent |
| Decision date | 2019-11-15 |
| Date received | 2019-05-06 |
| Product code | DZE |
| Device class | 2 |
| Medical specialty | Dental |
| Applicant location | PA, US |
| Source | openFDA device |
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$1999/mo
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