TN-Brush— 510(k) K170596

Substantially Equivalent

Genoss Co., Ltd.

FDA 510(k) clearance K170596 for TN-Brush, Substantially Equivalent on 2017-09-11. Applicant: Genoss Co., Ltd.. Device class: 2.

Clearance details

Applicant: Genoss Co., Ltd.
Product code: Code ELB
Device class: Class 2
Regulation: 21 CFR 872.4840
Advisory panel: Dental
Date received: 2017-02-28
Decision date: 2017-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code ELB

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K782007 — ROTARY SCALER1979-01-03

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Data sourced from openFDA. This site is unofficial and independent of the FDA.