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FDA 510(k)

PRESIDENT The Original

K-Number: K220097 · 2022-01-13

ApplicantColtène/Whaledent AG
Decision Date2022-01-13
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PRESIDENT The Original is the device name listed in this FDA 510(k) record. The listed applicant is Coltène/Whaledent AG. It received FDA 510(k) clearance on 2022-01-13 under 510(k) number K220097. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESIDENT The Original?

PRESIDENT The Original is a medical device that received FDA 510(k) clearance on 2022-01-13. The listed applicant is Coltène/Whaledent AG. The 510(k) number is K220097.

When did PRESIDENT The Original receive FDA 510(k) clearance?

PRESIDENT The Original received FDA 510(k) clearance on 2022-01-13, under 510(k) number K220097.

Who is the listed applicant for PRESIDENT The Original?

The FDA 510(k) record lists Coltène/Whaledent AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRESIDENT The Original?

The FDA product code for PRESIDENT The Original is ELW.

Related Devices (Code: ELW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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