Elos Accurate Customized Abutment, Elos Prosthetic Screw
K-Number: K171799 · 2018-01-15
ApplicantElos Medtech Pinol A/S
Decision Date2018-01-15
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Elos Accurate Customized Abutment, Elos Prosthetic Screw is a medical device manufactured by Elos Medtech Pinol A/S. It received FDA 510(k) clearance on 2018-01-15 under approval number K171799. 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 Prosthetic Screw?
Elos Accurate Customized Abutment, Elos Prosthetic Screw is a medical device that received FDA 510(k) clearance on 2018-01-15. It is manufactured by Elos Medtech Pinol A/S. The 510(k) number is K171799.
When was Elos Accurate Customized Abutment, Elos Prosthetic Screw approved by the FDA?
Elos Accurate Customized Abutment, Elos Prosthetic Screw received FDA 510(k) clearance on 2018-01-15, under approval number K171799.
What company makes Elos Accurate Customized Abutment, Elos Prosthetic Screw?
Elos Accurate Customized Abutment, Elos Prosthetic Screw is manufactured by Elos Medtech Pinol A/S.
What is the FDA product code for Elos Accurate Customized Abutment, Elos Prosthetic Screw?
The FDA product code for Elos Accurate Customized Abutment, Elos Prosthetic Screw 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.