PRESIDENT The Original— 510(k) K220097
Substantially EquivalentColtène/Whaledent AG
FDA 510(k) clearance K220097 for PRESIDENT The Original, Substantially Equivalent on 2022-01-13. Applicant: Coltène/Whaledent AG. Device class: 2.
Clearance details
- Applicant
- Coltène/Whaledent AG
- Product code
- Code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Altstätten, CH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.