NEOSIL Co., Ltd

Address:54, Soto-ro, Sangbuk-myeon,Yangsan-si Gyeongnam,KR

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Material, Impression (ELW) (2)

Premarket Exempt

Clear

PEAKOSIL - 08800026400127 Catalog Number :

Device Description : Product Name: PEAKOSIL One-Time PuttyThis product is a convenience kit of Putty( Product Name: PEAKOSIL One-Time PuttyThis product is a convenience kit of Putty(MSP).This product changed only in packaging materials from Putty.These changes don't cause any change from the original functions of Putty.Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).

Device Class :

Duns Number: 690409169

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

PEAKOSIL - 08800026400134 Catalog Number :

Device Description : Product Name : Teeth impressions kitThis product is a convenience kit including Product Name : Teeth impressions kitThis product is a convenience kit including One-time Putty 3EA and 6 dental impression trays.The contents of this kit are all registered in FDA.Its content, One-time Putty is a convenience kit that is changed only in packaging materials from Putty(MSP).These changes don't cause any change in the original functions of Putty.Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).

Device Class : 2

Duns Number: 690409169

Premarket Exempt : No

Product Code : ELW

Prescription Use : No

Device Count : 1

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