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FDA 510(k)

Dentalis Bio Solution Implants

K-Number: K161281 · 2017-01-11

ApplicantDentalis Bio Solution Implants, LLC
Decision Date2017-01-11
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Dentalis Bio Solution Implants is the device name listed in this FDA 510(k) record. The listed applicant is Dentalis Bio Solution Implants, LLC. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K161281. 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 Dentalis Bio Solution Implants?

Dentalis Bio Solution Implants is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Dentalis Bio Solution Implants, LLC. The 510(k) number is K161281.

When did Dentalis Bio Solution Implants receive FDA 510(k) clearance?

Dentalis Bio Solution Implants received FDA 510(k) clearance on 2017-01-11, under 510(k) number K161281.

Who is the listed applicant for Dentalis Bio Solution Implants?

The FDA 510(k) record lists Dentalis Bio Solution Implants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dentalis Bio Solution Implants?

The FDA product code for Dentalis Bio Solution 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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