PEAK NS033CF, PEAK NS017CF
Neosil Co., Ltd
NEOSIL CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3012173918 | 3012173918 | NEOSIL CO., LTD. | 1 | N | 2020-04-25 | 54, Soto-ro, Sangbuk-myeon Yangsan-si Gyeongsangnamdo KR 50566 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 188090 | 1188531524 | K180565 | PEAK NS033CF, PEAK NS017CF | ELW | 2018-06-13 |
| 188090 | 1864679704 | K152180 | PEAK | ELW | 2015-10-22 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| ELW | 2 | 2018-06-13 |
PMN#
PEAK
Neosil Co., Ltd
GUDID#
PEAKOSIL - Product Name:PEAKOSIL Light Body Regular Set
2017-09-21
PEAKOSIL - Product Name: PEAKOSIL Monophase Regular SetThis product has another model number, NS024C.
2019-01-07
PEAKOSIL - Product Name:PEAKOSIL Heavy Body Fast Set
2019-01-07
PEAKOSIL - Product Name:PEAKOSIL Light Body Fast Set
2019-01-07
PEAKOSIL - Product Name: PEAKOSIL Heavy Body Regular Set
2017-09-20
PEAKOSIL - Product Name:PEAKOSIL Bite Regular Set.This product has another model number, NS011C which is registered in other countries.
2019-01-07
PEAKOSIL - 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).
2020-01-03
PEAKOSIL - 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).
2017-09-21
PEAKOSIL - 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).
2020-01-03
PEAKOSIL - 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).
2017-09-21
PEAKOSIL - 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.
2017-09-21
PEAKOSIL - Product Name: Light Body
2017-09-21
PEAKOSIL - Product Name: Monophase This product has another model number, NS024C.
2019-01-07
PEAKOSIL - Product Name: Start Kit This 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).
2017-09-21
PEAKOSIL - Product Name : Start Kit This original PEAKOSIL Start Kit(NSSK) is a kit including 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.
2017-09-21
PEAKOSIL - Product Name: Heavy Body Fast Set
2019-01-07
PEAKOSIL - Product Name: Light Body Fast Set
2019-01-07
PEAKOSIL - Product Name: Heavy Body Tube
2019-01-03