FDA 510(k)

AbutmentCAD

K-Number: K193352 · 2021-07-21

Decision Date2021-07-21

Product CodePNP

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

AbutmentCAD is the device name listed in this FDA 510(k) record. The listed applicant is Exocad GmbH. It received FDA 510(k) clearance on 2021-07-21 under 510(k) number K193352. The device is classified under product code PNP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AbutmentCAD?

AbutmentCAD is a medical device that received FDA 510(k) clearance on 2021-07-21. The listed applicant is Exocad GmbH. The 510(k) number is K193352.

When did AbutmentCAD receive FDA 510(k) clearance?

AbutmentCAD received FDA 510(k) clearance on 2021-07-21, under 510(k) number K193352.

Who is the listed applicant for AbutmentCAD?

The FDA 510(k) record lists Exocad GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AbutmentCAD?

The FDA product code for AbutmentCAD is PNP.

Other records listing Exocad GmbH as applicant

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.

K213302exoplan K183458exoplan 2.3

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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.