Custom Abutments
K-Number: K243278 · 2025-02-21
ApplicantInstitut Straumann AG
Decision Date2025-02-21
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Custom Abutments is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2025-02-21 under approval number K243278. 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 Custom Abutments?
Custom Abutments is a medical device that received FDA 510(k) clearance on 2025-02-21. It is manufactured by Institut Straumann AG. The 510(k) number is K243278.
When was Custom Abutments approved by the FDA?
Custom Abutments received FDA 510(k) clearance on 2025-02-21, under approval number K243278.
What company makes Custom Abutments?
Custom Abutments is manufactured by Institut Straumann AG.
What is the FDA product code for Custom Abutments?
The FDA product code for Custom Abutments 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.