OPTIMUS CMF SYSTEM— 510(k) K160363
Substantially EquivalentOsteonic Co., Ltd.
FDA 510(k) clearance K160363 for OPTIMUS CMF SYSTEM, Substantially Equivalent on 2016-10-20. Applicant: Osteonic Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Osteonic Co., Ltd.
- Product code
- Code JEY
- Device class
- Class 2
- Regulation
- 21 CFR 872.4760
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Seoul, KR
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More clearances from Osteonic Co., Ltd.
view allAdverse events under product code JEY
product code JEY- Injury
- 1,542
- Malfunction
- 2,292
- Total
- 3,834
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.