No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 08800026400103 | NS017T | Product Name: Heavy Body Tube | ELW | Material, Impression | 2 | PEAKOSIL | |
2 | 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). | ELW | Material, Impression | 2 | PEAKOSIL | |
3 | 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). | ELW | Material, Impression | PEAKOSIL | ||
4 | 08800026400097 | NS033CF | Product Name:PEAKOSIL Light Body Fast Set | ELW | Material, Impression | PEAKOSIL | ||
5 | 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. | ELW | Material, Impression | 2 | PEAKOSIL | |
6 | 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). | ELW | Material, Impression | 2 | PEAKOSIL | |
7 | 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). | ELW | Material, Impression | PEAKOSIL | ||
8 | 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. | ELW | Material, Impression | PEAKOSIL | ||
9 | 08800026400028 | MSRC | Product Name: PEAKOSIL Monophase Regular SetThis product has another model number, NS024C. | ELW | Material, Impression | PEAKOSIL | ||
10 | 08800026400011 | NS033C | Product Name:PEAKOSIL Light Body Regular Set | ELW | Material, Impression | PEAKOSIL | ||
11 | 08800026400004 | NS017C | Product Name: PEAKOSIL Heavy Body Regular Set | ELW | Material, Impression | PEAKOSIL |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00842452100712 | 600-643M | 600-643M | Chromatic (Color Changing) Impression Material For Dental Molds / Mint Flavor | Allgilloid Plus™ Chromatic Mint Alginate | ORTHO SPECIALTIES |
2 | 00842452100705 | 600-643C | 600-643C | Chromatic (Color Changing) Impression Material For Dental Molds / Cherry Flavor | Allgilloid Plus™ Chromatic Cherry Alginate | ORTHO SPECIALTIES |
3 | E217S135601 | 13560 | 13560 | Panasil tray Soft Heavy Fast Test pack | Panasil | KETTENBACH GMBH & CO. KG |
4 | E217S134001 | S13400 | S13400 | Panasil initial contact X-Light Test Pack | Panasil | KETTENBACH GMBH & CO. KG |
5 | E21728310111 | 2831011 | 2831011 | Panasil initial contact Light Bonus pack | Panasil | KETTENBACH GMBH & CO. KG |
6 | E217283101 | 28310 | 28310 | Panasil initial contact Light Bonus pack | Panasil | KETTENBACH GMBH & CO. KG |
7 | E21728300111 | 2830011 | 2830011 | Panasil initial contact X-Light Bonus pack | Panasil | KETTENBACH GMBH & CO. KG |
8 | E217283001 | 28300 | 28300 | Panasil initial contact X-Light Bonus pack | Panasil | KETTENBACH GMBH & CO. KG |
9 | E21728279111 | 2827911 | 2827911 | Futar D Fast Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
10 | E217282791 | 28279 | 28279 | Futar D Fast Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
11 | E21728278111 | 2827811 | 2827811 | Futar D Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
12 | E217282781 | 28278 | 28278 | Futar D Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
13 | E21728277111 | 2827711 | 2827711 | Futar Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
14 | E217282771 | 28277 | 28277 | Futar Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
15 | E21728276111 | 2827611 | 2827611 | Futar Fast Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
16 | E217282761 | 28276 | 28276 | Futar Fast Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
17 | E21728275111 | 2827511 | 2827511 | Futar Cut & Trim Fast Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
18 | E217282751 | 28275 | 28275 | Futar Cut & Trim Fast Bonus pack | Futar | KETTENBACH GMBH & CO. KG |
19 | E217281451 | 28145 | 28145 | Panasil contact two in one Light Promotion pack | Panasil | KETTENBACH GMBH & CO. KG |
20 | E21728144111 | 2814411 | 2814411 | Panasil contact plus X-Light Promotion pack | Panasil | KETTENBACH GMBH & CO. KG |
21 | E217281441 | 28144 | 28144 | Panasil contact plus X-Light Promotion pack | Panasil | KETTENBACH GMBH & CO. KG |
22 | E217281271 | 28127 | 28127 | Panasil Putty Fast Set Promotion pack | Panasil | KETTENBACH GMBH & CO. KG |
23 | E217281261 | 28126 | 28126 | Panasil Putty Soft Promotion pack | Panasil | KETTENBACH GMBH & CO. KG |
24 | E217147271 | 14727 | 14727 | Identium Heavy Fast Refill pack | Identium | KETTENBACH GMBH & CO. KG |
25 | E217147261 | 14726 | 14726 | Identium Heavy Fast Intro pack | Identium | KETTENBACH GMBH & CO. KG |
26 | E217147251 | 14725 | 14725 | Identium Heavy Refill pack | Identium | KETTENBACH GMBH & CO. KG |
27 | E217147241 | 14724 | 14724 | Identium Heavy Intro pack | Identium | KETTENBACH GMBH & CO. KG |
28 | E217147191 | 14719 | 14719 | Identium Medium Fast Refill pack | Identium | KETTENBACH GMBH & CO. KG |
29 | E217147181 | 14718 | 14718 | Identium Medium Fast Intro pack | Identium | KETTENBACH GMBH & CO. KG |
30 | E217147171 | 14717 | 14717 | Identium Medium Refill pack | Identium | KETTENBACH GMBH & CO. KG |
31 | E217147161 | 14716 | 14716 | Identium Medium Intro pack | Identium | KETTENBACH GMBH & CO. KG |
32 | E217147151 | 14715 | 14715 | Silginat Strawberry Refill pack | Silginat | KETTENBACH GMBH & CO. KG |
33 | E217147141 | 14714 | 14714 | Silginat Strawberry Intro pack | Silginat | KETTENBACH GMBH & CO. KG |
34 | E217147131 | 14713 | 14713 | Silginat Refill pack | Silginat | KETTENBACH GMBH & CO. KG |
35 | E217147121 | 14712 | 14712 | Silginat Intro pack | Silginat | KETTENBACH GMBH & CO. KG |
36 | E217147091 | 14709 | 14709 | Panasil monophase Medium Refill pack | Panasil | KETTENBACH GMBH & CO. KG |
37 | E217147081 | 14708 | 14708 | Panasil monophase Medium Intro pack | Panasil | KETTENBACH GMBH & CO. KG |
38 | E217147071 | 14707 | 14707 | Panasil tray Soft Heavy Refill pack | Panasil | KETTENBACH GMBH & CO. KG |
39 | E217147061 | 14706 | 14706 | Panasil tray Soft Heavy Intro pack | Panasil | KETTENBACH GMBH & CO. KG |
40 | E217147051 | 14705 | 14705 | Panasil tray Fast Heavy Intro pack | Panasil | KETTENBACH GMBH & CO. KG |
41 | E217147041 | 14704 | 14704 | Panasil tray Fast Heavy Intro pack | Panasil | KETTENBACH GMBH & CO. KG |
42 | E217147031 | 14703 | 14703 | Panasil binetics Putty Soft Refill pack | Panasil | KETTENBACH GMBH & CO. KG |
43 | E217147021 | 14702 | 14702 | Panasil binetics Putty Soft Intro pack | Panasil | KETTENBACH GMBH & CO. KG |
44 | E217147011 | 14701 | 14701 | Panasil binetics Putty Fast Refill pack | Panasil | KETTENBACH GMBH & CO. KG |
45 | E217147001 | 14700 | 14700 | Panasil binetics Putty Fast Intro pack | Panasil | KETTENBACH GMBH & CO. KG |
46 | E217138481 | 13848 | 13848 | Silginat Superbulk | Silginat | KETTENBACH GMBH & CO. KG |
47 | E21713847111 | 1384711 | 1384711 | Silginat Bulk pack | Silginat | KETTENBACH GMBH & CO. KG |
48 | E217138471 | 13847 | 13847 | Silginat Bulk pack | Silginat | KETTENBACH GMBH & CO. KG |
49 | E21713846111 | 1384611 | 1384611 | Silginat Normal pack | Silginat | KETTENBACH GMBH & CO. KG |
50 | E217138461 | 13846 | 13846 | Silginat Normal pack | Silginat | KETTENBACH GMBH & CO. KG |