Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
K-Number: K260460 · 2026-05-07
ApplicantInstitut Straumann AG
Decision Date2026-05-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2026-05-07 under approval number K260460. 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 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue?
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue is a medical device that received FDA 510(k) clearance on 2026-05-07. It is manufactured by Institut Straumann AG. The 510(k) number is K260460.
When was Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue approved by the FDA?
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue received FDA 510(k) clearance on 2026-05-07, under approval number K260460.
What company makes Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue?
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue is manufactured by Institut Straumann AG.
What is the FDA product code for Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue?
The FDA product code for Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue is NHA.
Related Devices (Code: NHA)
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.