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FDA 510(k)

Simply Iconic Implants

K-Number: K201553 · 2021-01-22

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2021-01-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Simply Iconic Implants is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2021-01-22 under 510(k) 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. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K201553.

When did Simply Iconic Implants receive FDA 510(k) clearance?

Simply Iconic Implants received FDA 510(k) clearance on 2021-01-22, under 510(k) number K201553.

Who is the listed applicant for Simply Iconic Implants?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simply Iconic Implants?

The FDA product code for Simply Iconic Implants is DZE.

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Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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