Nobel Biocare S Series Implants
K-Number: K252197 · 2026-02-18
ApplicantNobel Biocare AB
Decision Date2026-02-18
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Nobel Biocare S Series Implants is a medical device manufactured by Nobel Biocare AB. It received FDA 510(k) clearance on 2026-02-18 under approval number K252197. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Nobel Biocare S Series Implants?
Nobel Biocare S Series Implants is a medical device that received FDA 510(k) clearance on 2026-02-18. It is manufactured by Nobel Biocare AB. The 510(k) number is K252197.
When was Nobel Biocare S Series Implants approved by the FDA?
Nobel Biocare S Series Implants received FDA 510(k) clearance on 2026-02-18, under approval number K252197.
What company makes Nobel Biocare S Series Implants?
Nobel Biocare S Series Implants is manufactured by Nobel Biocare AB.
What is the FDA product code for Nobel Biocare S Series Implants?
The FDA product code for Nobel Biocare S Series Implants is DZE.
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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.