Simply Iconic Implants
K-Number: K201553 · 2021-01-22
Decision Date2021-01-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Simply Iconic Implants is a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2021-01-22 under approval number K201553. 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 Simply Iconic Implants?
Simply Iconic Implants is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K201553.
When was Simply Iconic Implants approved by the FDA?
Simply Iconic Implants received FDA 510(k) clearance on 2021-01-22, under approval number K201553.
What company makes Simply Iconic Implants?
Simply Iconic Implants is manufactured by Implant Direct Sybron Manufacturing, LLC.
What is the FDA product code for Simply Iconic Implants?
The FDA product code for Simply Iconic Implants is DZE.
Other Devices by Implant Direct Sybron Manufacturing, LLC
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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.