Elos Accurate® Customized Abutment
K-Number: K190299 · 2019-06-26
ApplicantElos Medtech Pinol A/S
Decision Date2019-06-26
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Elos Accurate® Customized Abutment is a medical device manufactured by Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2019-06-26 under approval number K190299. 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 Elos Accurate® Customized Abutment?
Elos Accurate® Customized Abutment is a medical device that received FDA 510(k) clearance on 2019-06-26. It is manufactured by Elos Medtech Pinol A/S. The 510(k) number is K190299.
When was Elos Accurate® Customized Abutment approved by the FDA?
Elos Accurate® Customized Abutment received FDA 510(k) clearance on 2019-06-26, under approval number K190299.
What company makes Elos Accurate® Customized Abutment?
Elos Accurate® Customized Abutment is manufactured by Elos Medtech Pinol A/S.
What is the FDA product code for Elos Accurate® Customized Abutment?
The FDA product code for Elos Accurate® Customized Abutment is NHA.
Related Clinical Trials
Other Devices by Elos Medtech Pinol A/S
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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.