No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | D023P006350 | P00635 | P00635 | Quala gut chromic 4/0 27 C-6 suture absorbable | GAL | Suture, Absorbable, Natural | 2 | Quala Chromic Gut Suture |
2 | D023P005580 | P00558 | P00558 | Quala chromic gut 4/0 18 C-6 absorbable suture | GAL | Suture, Absorbable, Natural | 2 | Quala Chromic Gut Suture |
3 | D23Q4001217 | Q40012 | Q40012 | Quala Etch Gel Econo Kit 12-1.2ML Gel 50 Tips | KLE | Agent, Tooth Bonding, Resin | Quala | |
4 | D023QUIN100025K1 | QUIN-100025K | QUIN-100025K | Quala Ultrasonic Insert 1000 25K DR 3-Bend Each | ELC | Scaler, Ultrasonic | 2 | Quala |
5 | D023QUIN1030K19 | QUIN-1030K | QUNI-1030K | Quala Ultrasonic Insert 10 30 K DF Universal Each | ELC | Scaler, Ultrasonic | 2 | Quala |
6 | D023QUIN1025K1 | QUIN-1025K | QUIN-1025K | Quala Ultrasonic Insert 10 25K DF Universal Each | ELC | Scaler, Ultrasonic | 2 | Quala |
7 | D023QUIN10030K19 | QUIN-10030K | QUIN-10030K | Quala Ultrasonic Insert 100 30K DF Thin Style | ELC | Scaler, Ultrasonic | 2 | Quala |
8 | D023QUIN10025K1 | QUIN-10025K | QUIN-10025K | Quala Ultrasonic Insert 100 25K DF Thin Sytle Each | ELC | Scaler, Ultrasonic | 2 | Quala |
9 | D023Q900HP18 | Q-9000HP | Q-9000HP | Quala HP Bite Registration Super Fast Set | ELW | Material, Impression | 2 | Quala |
10 | D023Q9005HP1 | Q-9005HP | Q-9005HP | Quala Rigid Bite Registration Fast Set | ELW | Material, Impression | 2 | Quala |
11 | D023Q9005HP0 | Q-9005HP | Q-9005HP | Quala Rigid Bite Registration Fast Set | ELW | Material, Impression | 2 | Quala |
12 | D023Q9004HP1 | Q-9004HP | Q-9004HP | Quala HP Vanilla Bite Super Fast Set | ELW | Material, Impression | 2 | Quala |
13 | D023Q9004HP0 | Q-9004HP | Q-9004HP | Quala HP Vanilla Bite Super Fast Set | ELW | Material, Impression | 2 | Quala |
14 | D023Q9003HP1 | Q-9003HP | Q-9003HP | Quala HP Vanille Bite Fast Set | ELW | Material, Impression | 2 | Quala |
15 | D023Q9002HP1 | Q-9002HP | Q-9002HP | Quala HP Bite Registration Fast Set | ELW | Material, Impression | 2 | Quala |
16 | D023Q9002HP0 | Q-9002HP | Q-9002HP | Quala HP Bite Registration Fast Set | ELW | Material, Impression | 2 | Quala |
17 | D023Q9001HP19 | Q-9001HP | Q-9001HP | Quala HP Bite Registration Reg Set | ELW | Material, Impression | 2 | Quala |
18 | D023Q9001HP0 | Q-9001HP | Q-9001HP | Quala HP Bite Registration Reg Set | ELW | Material, Impression | 2 | Quala |
19 | D023Q9000HP0 | Q-9000HP | Q-9000HP | Quala HP Bite Registration Super Fast Set | ELW | Material, Impression | 2 | Quala |
20 | D023Q858061 | Q85806 | Q85806 | Quala Bleach Temporary C&B 10:1 Catridge | EBG | Crown And Bridge, Temporary, Resin | 2 | Quala |
21 | D023Q858051 | Q85805 | Q85805 | Quala B1 Temporary C & B 10:1 Cartridge | EBG | Crown And Bridge, Temporary, Resin | 2 | Quala |
22 | D023Q858041 | Q85804 | Q85804 | Quala A3.5 Temporary C & B 10:1 Cartridge | EBG | Crown And Bridge, Temporary, Resin | 2 | Quala |
23 | D023Q858031 | Q85803 | Q85803 | Quala A3 Temporary C & B 10:1 Cartridge | EBG | Crown And Bridge, Temporary, Resin | 2 | Quala |
24 | D023Q858021 | Q85802 | Q85802 | Quala A2 Temporary C & B 10:1 Cartidge | EBG | Crown And Bridge, Temporary, Resin | 2 | Quala |
25 | D023Q858011 | Q85801 | Q85801 | Quala A1 Temporary C & B 10:1 Cartridge | EBG | Crown And Bridge, Temporary, Resin | 2 | Quala |
26 | D023Q80211 | Q-8021 | Q-8021 | Quala Bayonet Ring Yellow 2/BG | EID | Syringe, Restorative And Impression Material | 1 | Quala |
27 | D023Q80201 | Q-8020 | Q-8020 | Quala Mixing Tips Dynamic 380 ML Yellow 50/BG | EID | Syringe, Restorative And Impression Material | 1 | Quala |
28 | D023Q6024521 | Q602452 | Q602452 | Quala Sterilization Monitoring 2-Strip M-I-Value | FRC | Indicator, Biological Sterilization Process | 2 | Quala |
29 | D023Q60244810 | Q602448 | Q602448 | Quala Sterilization Monitoring 3 strip M-I-T | FRC | Indicator, Biological Sterilization Process | 2 | Quala |
30 | D023Q6024121 | Q602412 | Q602412 | Quala Sterilization Monitoring 3-Strip M-I-T | FRC | Indicator, Biological Sterilization Process | 2 | Quala |
31 | D023Q6023351 | Q602335 | Q602335 | Quala CSR Wrap 20 X 20 | FRG | Wrap, Sterilization | 2 | Quala |
32 | D023Q6023301 | Q602330 | Q602330 | Quala CSR Wrap 15 X 15 | FRG | Wrap, Sterilization | 2 | Quala |
33 | D023Q6022401 | Q602340 | Q602340 | Quala CSR Wrap 24 X 24 | FRG | Wrap, Sterilization | 2 | Quala |
34 | D023Q5895121 | Q589512 | Q589512 | Quala Alginate Substitute 380ML Fast Set Mint | ELW | Material, Impression | 2 | Quala |
35 | D023Q5895120 | Q589512 | Q589512 | Quala Alginate Substitute 380ML Fast Set Mint | ELW | Material, Impression | 2 | Quala |
36 | D023Q5895101 | Q589510 | Q589510 | Quala Alginate Substitute 50ML Fast Set Mint | ELW | Material, Impression | 2 | Quala |
37 | D023Q5895100 | Q589510 | Q589510 | Quala Alginate Substitute 50ML Fast Set Mint | ELW | Material, Impression | 2 | Quala |
38 | D023Q402551 | Q40255 | Q40255 | Quala Flowable Composite B1 2X2G 20TIPS/PK | EBF | Material, Tooth Shade, Resin | 2 | Quala |
39 | D023Q402541 | Q40254 | Q40254 | Quala Flowable Composite A3.5 2.5G 20 TIPS/PK | EBF | Material, Tooth Shade, Resin | 2 | Quala |
40 | D023Q402531 | Q40253 | Q40253 | Quala Flowable Composite A3 2X2G 20TIPS/PK | EBF | Material, Tooth Shade, Resin | 2 | Quala |
41 | D023Q402521 | Q40252 | Q40252 | Quala Flowable Composite A2 2X2G 20 TIPS/PK | EBF | Material, Tooth Shade, Resin | 2 | Quala |
42 | D023Q402511 | Q40251 | Q40251 | Quala Flowable Composite A1 2x2G | EBF | Material, Tooth Shade, Resin | 2 | Quala |
43 | D023Q4020117 | Q40201 | Q40201 | Quala Core Buildup Dual Cure 2x9G 20 Mix Tip | EBF | Material, Tooth Shade, Resin | 2 | Quala |
44 | D023Q4003017 | Q40030 | Q40030 | Quala Etch Gel Jumbo Kit 2-30ML 50 Tips 3 Syringes | KLE | Agent, Tooth Bonding, Resin | 2 | Quala |
45 | D023Q400122ML19 | Q400122ML | Q400122ML | KLE | Agent, Tooth Bonding, Resin | 2 | Quala | |
46 | D023Q400042ML1 | Q400042ML | Q400042ML | Quala Etch Gel 2ml Syringe 4 Syringes 20 Tips | KLE | Agent, Tooth Bonding, Resin | 2 | Quala |
47 | D023Q4000418 | Q40004 | Q40004 | Quala Etch 1.2 ML Gel Syringe 4 Syringes 20 Tips | KLE | Agent, Tooth Bonding, Resin | 2 | Quala |
48 | D023Q0550301 | Q055030 | Q055030 | Quala Alloy Amalgam 3 Spill FS 50/JR | EJJ | Alloy, Amalgam | 2 | Quala |
49 | D023Q0550261 | Q055026 | Q055026 | Quala Alloy Amalgam 2 Spill FS 50/JR | EJJ | Alloy, Amalgam | 2 | Quala |
50 | D023Q0550221 | Q055022 | Q055022 | Quala Alloy Amalgam 1 Spill FS 50/JR | EJJ | Alloy, Amalgam | 2 | Quala |
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 |