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FDA 510(k)

SDS1.2 dental implant

K-Number: K181953 · 2019-11-20

ApplicantSds Swiss Dental Solutions AG
Decision Date2019-11-20
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SDS1.2 dental implant is the device name listed in this FDA 510(k) record. The listed applicant is Sds Swiss Dental Solutions AG. It received FDA 510(k) clearance on 2019-11-20 under 510(k) number K181953. 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 SDS1.2 dental implant?

SDS1.2 dental implant is a medical device that received FDA 510(k) clearance on 2019-11-20. The listed applicant is Sds Swiss Dental Solutions AG. The 510(k) number is K181953.

When did SDS1.2 dental implant receive FDA 510(k) clearance?

SDS1.2 dental implant received FDA 510(k) clearance on 2019-11-20, under 510(k) number K181953.

Who is the listed applicant for SDS1.2 dental implant?

The FDA 510(k) record lists Sds Swiss Dental Solutions AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SDS1.2 dental implant?

The FDA product code for SDS1.2 dental implant is DZE.

Other records listing Sds Swiss Dental Solutions AG as applicant

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.

K190406SDS2.2 dental implant

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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