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Device Description : Product Name: PEAKOSIL Heavy Body Regular Set
Device Class :
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name:PEAKOSIL Light Body Regular Set
Device Class :
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name: PEAKOSIL Monophase Regular SetThis product has another model number, NS024C.
Device Class :
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name:PEAKOSIL Bite Regular Set.This product has another model number, NS Product Name:PEAKOSIL Bite Regular Set.This product has another model number, NS011C which is registered in other countries.
Device Class :
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name: PuttyThis product has another model number, NS005P which is regist Product Name: PuttyThis product has another model number, NS005P which is registered in other countries.This product has a convenience kit, NS005P-1 that only changed only in packaging materials which don't cause any change from the original functions.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
Prescription Use : No
Device Description : Product Name: Start KitThis product is a customized Start Kit that one content o Product Name: Start KitThis product is a customized Start Kit that one content of the kit was replaced with the other product comparing to the ordinary Start Kit.It includes Light Body 1 EA, Heavy Body 1 EA, Putty 1 EA, Yellow Mix Tip 3 EA, Intra Oral Tip 3 EA & Green Mix Tip 3 EA instead of the contents of ordinary Start Kit(NSSK).
Device Class : 2
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name : Start KitThis original PEAKOSIL Start Kit(NSSK) is a kitincluding Product Name : Start KitThis original PEAKOSIL Start Kit(NSSK) is a kitincluding PEAKOSIL Light Body 2 EA, PEAKOSIL Putty 1 EA, Yellow Mix Tip 6 EA & Intra Oral Tip 6 EA.The contents of this kit are all registered in FDA.
Device Class : 2
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name:PEAKOSIL Heavy Body Fast Set
Device Class :
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name:PEAKOSIL Light Body Fast Set
Device Class :
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No
Device Description : Product Name: Heavy Body Tube
Device Class : 2
Duns Number: 690409169
Premarket Exempt : No
Prescription Use : No