FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)— 510(k) K242675

Name: FDA 510(k) clearance K242675
Creator: U.S. Food and Drug Administration
Published: 2024-11-01

Substantially Equivalent

Spident Co., Ltd.

FDA 510(k) clearance K242675 for FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack), Substantially Equivalent on 2024-11-01. Applicant: Spident Co., Ltd.. Device class: 2.

Clearance details

Applicant: Spident Co., Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2024-09-06
Decision date: 2024-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, KR

Download summary PDF View on FDA.gov ↗

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