Elos Accurate Customized Abutment
K-Number: K191890 · 2020-02-06
ApplicantElos Medtech Pinol A/S
Decision Date2020-02-06
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 2020-02-06 under approval number K191890. 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 2020-02-06. It is manufactured by Elos Medtech Pinol A/S. The 510(k) number is K191890.
When was Elos Accurate Customized Abutment approved by the FDA?
Elos Accurate Customized Abutment received FDA 510(k) clearance on 2020-02-06, under approval number K191890.
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.
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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.