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FDA 510(k)

Multi-unit Abutments

K-Number: K191123 · 2020-01-06

Decision Date2020-01-06
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Multi-unit Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Medentika GmbH. It received FDA 510(k) clearance on 2020-01-06 under 510(k) number K191123. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Multi-unit Abutments?

Multi-unit Abutments is a medical device that received FDA 510(k) clearance on 2020-01-06. The listed applicant is Medentika GmbH. The 510(k) number is K191123.

When did Multi-unit Abutments receive FDA 510(k) clearance?

Multi-unit Abutments received FDA 510(k) clearance on 2020-01-06, under 510(k) number K191123.

Who is the listed applicant for Multi-unit Abutments?

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

What is the FDA product code for Multi-unit Abutments?

The FDA product code for Multi-unit Abutments is NHA.

Other records listing Medentika 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.

View all 8 devices →

Related Devices (Code: NHA)

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.

Official Source

View on FDA Database →

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