Elos Accurate Customized Abutment
K-Number: K231307 · 2023-12-21
ApplicantElos Medtech Pinol A/S
Decision Date2023-12-21
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 2023-12-21 under approval number K231307. 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 2023-12-21. It is manufactured by Elos Medtech Pinol A/S. The 510(k) number is K231307.
When was Elos Accurate Customized Abutment approved by the FDA?
Elos Accurate Customized Abutment received FDA 510(k) clearance on 2023-12-21, under approval number K231307.
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.