Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Sds Swiss Dental Solutions AG. It received FDA 510(k) clearance on 2019-11-20 under approval 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. It is manufactured by Sds Swiss Dental Solutions AG. The 510(k) number is K181953.

When was SDS1.2 dental implant approved by the FDA?

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

What company makes SDS1.2 dental implant?

SDS1.2 dental implant is manufactured by Sds Swiss Dental Solutions AG.

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

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

Related Clinical Trials

NCT07605286 Soft Tissue Augmentation Around Dental Implants COMPLETED NCT07589140 Influence of Alveolar Bone Drilling and Anatomical Position on Integration NOT_YET_RECRUITING NCT07246499 Multicentre Study on the Impact of Transmucosal Abutment Surface Characteristics on Peri-implant Tissues. ACTIVE_NOT_RECRUITING NCT07240493 BMP Effect on Implant Stability and Marginal Bone Level After Immediate Placement COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT07580495 Effect of Collagen Membrane on Ridge Preservation NOT_YET_RECRUITING

Other Devices by Sds Swiss Dental Solutions AG

K190406SDS2.2 dental implant

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., 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.

↑