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FDA 510(k)

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)

K-Number: K242675 · 2024-11-01

ApplicantSpident Co., Ltd.
Decision Date2024-11-01
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) is a medical device manufactured by Spident Co., Ltd.. It received FDA 510(k) clearance on 2024-11-01 under approval number K242675. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)?

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Spident Co., Ltd.. The 510(k) number is K242675.

When was FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) approved by the FDA?

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) received FDA 510(k) clearance on 2024-11-01, under approval number K242675.

What company makes FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)?

FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) is manufactured by Spident Co., Ltd..

What is the FDA product code for FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)?

The FDA product code for FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) is KLE.

Other Devices by Spident Co., Ltd.

K161774i-Sil K214076EsCem K214071Hexa-Temp K231523EsCom250 K242702VioSeal K241445K-Bond Universal

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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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