Neodent Implant System - Helix Short Surgical Kit Cases
K-Number: K223662 · 2023-04-20
Decision Date2023-04-20
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Neodent Implant System - Helix Short Surgical Kit Cases is a medical device manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. It received FDA 510(k) clearance on 2023-04-20 under approval number K223662. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Neodent Implant System - Helix Short Surgical Kit Cases?
Neodent Implant System - Helix Short Surgical Kit Cases is a medical device that received FDA 510(k) clearance on 2023-04-20. It is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A.. The 510(k) number is K223662.
When was Neodent Implant System - Helix Short Surgical Kit Cases approved by the FDA?
Neodent Implant System - Helix Short Surgical Kit Cases received FDA 510(k) clearance on 2023-04-20, under approval number K223662.
What company makes Neodent Implant System - Helix Short Surgical Kit Cases?
Neodent Implant System - Helix Short Surgical Kit Cases is manufactured by Jjgc Industria E Comercio DE Materiais Dentarios S.A..
What is the FDA product code for Neodent Implant System - Helix Short Surgical Kit Cases?
The FDA product code for Neodent Implant System - Helix Short Surgical Kit Cases is KCT.
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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.