| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | E217172601 | 17260 | 17260 | Intraoral tips, transparent, ø 1,0 mm | EID | Syringe, Restorative And Impression Material | 1 | Intraoral Tips |
| 2 | E217172591 | 17259 | 17259 | Intraoral tips, transparent, ø 0,6 mm | EID | Syringe, Restorative And Impression Material | 1 | Intraoral Tips |
| 3 | E217172251 | 17225 | 17225 | Intraoral tips, yellow, ø 1.0 mm | EID | Syringe, Restorative And Impression Material | 1 | Intraoral Tips |
| 4 | E217172231 | 17223 | 17223 | Intraoral tips, transparent, ø 1.2 mm | EID | Syringe, Restorative And Impression Material | 1 | Intraoral Tips |
| 5 | E217172221 | 17222 | 17222 | Intraoral tips, yellow, ø 1.0 mm | EID | Syringe, Restorative And Impression Material | 1 | Intraoral Tips |
| 6 | E217172211 | 17221 | 17221 | Intraoral tips, transparent, ø 1.0 mm | EID | Syringe, Restorative And Impression Material | 1 | Intraoral Tips |
| 7 | E217138711 | 13871 | 13871 | Visalys Core Dentin Cartridge Normal pack | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 8 | E217138701 | 13870 | 13870 | Visalys Core White Cartridge Normal pack | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 9 | E217138661 | 13866 | 13866 | Visalys Core White Syringe Intro pack | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 10 | E217138651 | 13865 | 13865 | Visalys Core Dentin Syringe Intro pack | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 11 | E217138641 | 13864 | 13864 | Visalys Core Dentin Syringe Sample | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 12 | E217138631 | 13863 | 13863 | Visalys Core White Syringe Sample | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 13 | E217138611 | 13861 | 13861 | Visalys Core Dentin Syringe Normal pack | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 14 | E217138601 | 13860 | 13860 | Visalys Core White Syringe Normal pack | EBF | Material, Tooth Shade, Resin | 2 | Visalys Core |
| 15 | E217223011 | 22301 | 22301 | Kisol foil | EHY | Tray, Impression, Preformed | 1 | Kisol |
| 16 | E217172541 | 17254 | 17254 | Mixing tips, red, ø 4.0 mm500 tips | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 17 | E217172501 | 17250 | 17250 | Mixing tips, red, ø 4.0 mm100 tips | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 18 | E217172491 | 17249 | 17249 | Mixing tips, red, ø 4.0 mm50 tips | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 19 | E217172471 | 17247 | 17247 | Mixing tips, blue, ø 6.0 mm500 tips | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 20 | E217172461 | 17246 | 17246 | Mixing tips, blue, ø 6.0 mm100 tips | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 21 | E217172441 | 17244 | 17244 | Mixing tips, blue, ø 6.0 mm50 tips | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 22 | E217172421 | 17242 | 17242 | Mixing tips, yellow, ø 4.2 mm | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 23 | E217172401 | 17240 | 17240 | Mixing tips, yellow, ø 4.2 mm | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 24 | E217172381 | 17238 | 17238 | Mixing tips, blue, blunt, ø 2,5 mm50 tips for Visalys CemCore | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 25 | E217172361 | 17236 | 17236 | Mixing tips, blue, tapered, ø 2,5 mm50 tips for Visalys CemCore | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 26 | E217172351 | 17235 | 17235 | Mixing tips, green, ø 6.5 mm | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 27 | E217172341 | 17234 | 17234 | Mixing tips, green, ø 6.5 mm | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 28 | E217172321 | 17232 | 17232 | Mixing Tips, brown, ø 2.5 mm | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 29 | E217172301 | 17230 | 17230 | Mixing tips, yellow short, ø 4.2 mm | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 30 | E217172171 | 17217 | 17217 | Mixing tips, blue, ø 3.2 mm | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 31 | E217172071 | 17207 | 17207 | Syringe tips for Applyfix 550 pieces | EID | Syringe, Restorative And Impression Material | 1 | Syringe tips |
| 32 | E217137891 | 13789 | 13789 | Mixing tips, blue-orange, ø 3.2 mm50 tips for Visalys Temp | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 33 | E217011391 | 01139 | 01139 | Mixing tips, green, ø 6.5 mm500 tips | EID | Syringe, Restorative And Impression Material | 1 | Mixing Tips |
| 34 | E21728278111 | 2827811 | 2827811 | Futar D Bonus pack | ELW | Material, Impression | 2 | Futar |
| 35 | E217282781 | 28278 | 28278 | Futar D Bonus pack | ELW | Material, Impression | 2 | Futar |
| 36 | E217282771 | 28277 | 28277 | Futar Bonus pack | ELW | Material, Impression | 2 | Futar |
| 37 | E21728276111 | 2827611 | 2827611 | Futar Fast Bonus pack | ELW | Material, Impression | 2 | Futar |
| 38 | E217282761 | 28276 | 28276 | Futar Fast Bonus pack | ELW | Material, Impression | 2 | Futar |
| 39 | E21711961111 | 1196111 | 1196111 | Futar D Fast Normal pack | ELW | Material, Impression | 2 | Futar |
| 40 | E21728275111 | 2827511 | 2827511 | Futar Cut & Trim Fast Bonus pack | ELW | Material, Impression | 2 | Futar |
| 41 | E217119181 | 11918 | 11918 | Futar Superbulk | ELW | Material, Impression | 2 | Futar |
| 42 | E21711912111 | 119121 | 119121 | Futar Normal pack | ELW | Material, Impression | 2 | Futar |
| 43 | E217282751 | 28275 | 28275 | Futar Cut & Trim Fast Bonus pack | ELW | Material, Impression | 2 | Futar |
| 44 | E217119121 | 11912 | 11912 | Futar Normal pack | ELW | Material, Impression | 2 | Futar |
| 45 | E217119611 | 11961 | 11961 | Futar D Fast Normal pack | ELW | Material, Impression | 2 | Futar |
| 46 | E217119701 | 11970 | 11970 | Futar Scan Sample | ELW | Material, Impression | 2 | Futar |
| 47 | E21728279111 | 2827911 | 2827911 | Futar D Fast Bonus pack | ELW | Material, Impression | 2 | Futar |
| 48 | E217282791 | 28279 | 28279 | Futar D Fast Bonus pack | ELW | Material, Impression | 2 | Futar |
| 49 | E217179001 | 17900 | 17900 | Dynamic mixers, blue | EID | Syringe, Restorative And Impression Material | 1 | Dynamic Mixers |
| 50 | E217119671 | 11967 | 11967 | Futar D Fast Bulk pack | ELW | Material, Impression | 2 | Futar |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 08800040674054 | ESS50M | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 2 | 08800040674047 | ESS50MFD | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 3 | 08800040674030 | ESS50MFB | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 4 | 08800040674023 | ESS50MF | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 5 | 08800040674016 | ESS50MB | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 6 | 08800040674009 | ESS50L | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 7 | 08800040673996 | ESS50LFD | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 8 | 08800040673989 | ESS50LFB | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 9 | 08800040673972 | ESS50LF | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 10 | 08800040673965 | ESS50LB | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 11 | 08800040673958 | ESS50H | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 12 | 08800040673941 | ESS50HFD | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 13 | 08800040673934 | ESS50HFB | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 14 | 08800040673927 | ESS50HF | HySil Super Fast Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 15 | 08800040673910 | ESS50HB | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 16 | 08800040673903 | ESS50EL | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 17 | 08800040673897 | ESS50B | HySil Impression Materials (Heavy, Mono, and Bite) | OSSTEM IMPLANT CO.,LTD. | ||
| 18 | 08800040673880 | ESS400P | HySil Impression Materials | OSSTEM IMPLANT CO.,LTD. | ||
| 19 | 08800040673873 | ESS380M | HySil Impression Materials (Heavy, Mono, and Bite) | OSSTEM IMPLANT CO.,LTD. | ||
| 20 | 08800040673866 | ESS380H | HySil Impression Materials (Heavy, Mono, and Bite) | OSSTEM IMPLANT CO.,LTD. | ||
| 21 | 08800026400134 | NS005P-2 | 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). | PEAKOSIL | NEOSIL CO., LTD | |
| 22 | 08800026400127 | NS005P-1 | 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). | PEAKOSIL | NEOSIL CO., LTD | |
| 23 | 08800026400103 | NS017T | Product Name: Heavy Body Tube | PEAKOSIL | NEOSIL CO., LTD | |
| 24 | 08800026400097 | NS033CF | Product Name:PEAKOSIL Light Body Fast Set | PEAKOSIL | NEOSIL CO., LTD | |
| 25 | 08800026400080 | NS017CF | Product Name:PEAKOSIL Heavy Body Fast Set | PEAKOSIL | NEOSIL CO., LTD | |
| 26 | 08800026400073 | NSSK | 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. | PEAKOSIL | NEOSIL CO., LTD | |
| 27 | 08800026400066 | NSSK-1 | 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). | PEAKOSIL | NEOSIL CO., LTD | |
| 28 | 08800026400042 | MSP | 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). | PEAKOSIL | NEOSIL CO., LTD | |
| 29 | 08800026400035 | MSBC | 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. | PEAKOSIL | NEOSIL CO., LTD | |
| 30 | 08800026400028 | MSRC | Product Name: PEAKOSIL Monophase Regular SetThis product has another model number, NS024C. | PEAKOSIL | NEOSIL CO., LTD | |
| 31 | 08800026400011 | NS033C | Product Name:PEAKOSIL Light Body Regular Set | PEAKOSIL | NEOSIL CO., LTD | |
| 32 | 08800026400004 | NS017C | Product Name: PEAKOSIL Heavy Body Regular Set | PEAKOSIL | NEOSIL CO., LTD | |
| 33 | 08800024204222 | Delikit Biggg Heavy Body(75ml* 2 Cartridges) | Delikit Biggg Heavy Body | SHERPAKOREA | ||
| 34 | 08800024203997 | Delikit 3.0 Light Body Fast(4.5ml*25Cartridges) | Delikit 3.0 Light Body Fast | SHERPAKOREA | ||
| 35 | 08800024203805 | Delikit 3.0 Light Body(4.5ml* 25 Cartridges) | Delikit 3.0 Light Body | SHERPAKOREA | ||
| 36 | 08800024203294 | Deli-Border (50ml * 2 Cartridges) | Deli-Border | SHERPAKOREA | ||
| 37 | 08800024203287 | Delikit Heavy Body fast (50ml * 2 Cartridges) | Delikit Heavy Body FS | SHERPAKOREA | ||
| 38 | 08800024203270 | Delikit Light Body fast (50ml * 2 Cartridges) | Delikit Light Body FS | SHERPAKOREA | ||
| 39 | 08800024203263 | Delikit 200 Heavy Body (200ml * 3 Cartridges) | Delikit 200 Heavy Body | SHERPAKOREA | ||
| 40 | 08800024203249 | Densurefit (2.4ml * 720 Cartridges) | Densurefit | SHERPAKOREA | ||
| 41 | 08800024203232 | Delikit Bite Registration (50ml * 10 Cartridges) | Delikit Bite Registration | SHERPAKOREA | ||
| 42 | 08800024203225 | Delikit Light Body fast (50ml * 10 Cartridges) | Delikit Light Body FS | SHERPAKOREA | ||
| 43 | 08800024203218 | Delikit Light Body (50ml * 10 Cartridges) | Delikit Light Body | SHERPAKOREA | ||
| 44 | 08800024203201 | Delikit Medium Body (50ml * 10 Cartridges) | Delikit Medium Body | SHERPAKOREA | ||
| 45 | 08800024203195 | Delikit Heavy Body Fast (50ml * 10 Cartridges) | Delikit Heavy Body FS | SHERPAKOREA | ||
| 46 | 08800024203188 | Delikit Heavy Body (50ml * 10 Cartridges) | Delikit Heavy Body | SHERPAKOREA | ||
| 47 | 08800024203171 | Jackpot Bite (10ml * 100 Cartridges) | Jackpot Bite | SHERPAKOREA | ||
| 48 | 08800024203164 | Jackpot Light Body (10ml * 75 Cartridges) | Jackpot Light Body | SHERPAKOREA | ||
| 49 | 08800024203119 | Densurefit (2.4ml * 708 Cartridges) | Densurefit | SHERPAKOREA | ||
| 50 | 08800024203102 | Jackpot Light Body Fast (10ml * 10 Cartridges) | Jackpot Light Body Fast | SHERPAKOREA |