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)

i-Sil

K-Number: K161774 · 2016-09-30

ApplicantSpident Co., Ltd.
Decision Date2016-09-30
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

i-Sil is a medical device manufactured by Spident Co., Ltd.. It received FDA 510(k) clearance on 2016-09-30 under approval number K161774. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the i-Sil?

i-Sil is a medical device that received FDA 510(k) clearance on 2016-09-30. It is manufactured by Spident Co., Ltd.. The 510(k) number is K161774.

When was i-Sil approved by the FDA?

i-Sil received FDA 510(k) clearance on 2016-09-30, under approval number K161774.

What company makes i-Sil?

i-Sil is manufactured by Spident Co., Ltd..

What is the FDA product code for i-Sil?

The FDA product code for i-Sil is ELW.

Other Devices by Spident Co., Ltd.

K214076EsCem K214071Hexa-Temp K231523EsCom250 K242702VioSeal K242675FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) K241445K-Bond Universal

View all 9 devices →

Related Devices (Code: ELW)

K152615Vonflex SVericom Co., Ltd. K160097Image Fast Set, Image Regular SetSybron Dental Specialties K160441Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation K152826NoCordCentrix, Inc. K152766CharmFlexDentkist, Inc. K152861Aquasil Ultra + Smart Wetting Impression MaterialDentply International, Inc.

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.

↑