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FDA 510(k)

s-Clean OneQ-SL Narrow Implant System

K-Number: K161244 · 2016-12-07

Decision Date2016-12-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

s-Clean OneQ-SL Narrow Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2016-12-07 under 510(k) number K161244. 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 s-Clean OneQ-SL Narrow Implant System?

s-Clean OneQ-SL Narrow Implant System is a medical device that received FDA 510(k) clearance on 2016-12-07. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K161244.

When did s-Clean OneQ-SL Narrow Implant System receive FDA 510(k) clearance?

s-Clean OneQ-SL Narrow Implant System received FDA 510(k) clearance on 2016-12-07, under 510(k) number K161244.

Who is the listed applicant for s-Clean OneQ-SL Narrow Implant System?

The FDA 510(k) record lists Dentis Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for s-Clean OneQ-SL Narrow Implant System?

The FDA product code for s-Clean OneQ-SL Narrow Implant System is DZE.

Other records listing Dentis Co., Ltd. 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.

View all 31 devices →

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.

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.