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FDA 510(k)

IDCAM Dental Implants

K-Number: K200329 · 2021-04-22

ApplicantImplants Diffusion International
Decision Date2021-04-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IDCAM Dental Implants is the device name listed in this FDA 510(k) record. The listed applicant is Implants Diffusion International. It received FDA 510(k) clearance on 2021-04-22 under 510(k) number K200329. 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 IDCAM Dental Implants?

IDCAM Dental Implants is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Implants Diffusion International. The 510(k) number is K200329.

When did IDCAM Dental Implants receive FDA 510(k) clearance?

IDCAM Dental Implants received FDA 510(k) clearance on 2021-04-22, under 510(k) number K200329.

Who is the listed applicant for IDCAM Dental Implants?

The FDA 510(k) record lists Implants Diffusion International as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IDCAM Dental Implants?

The FDA product code for IDCAM Dental Implants is DZE.

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.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

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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