| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | H66809219991 | 0921999 | 0921999 | 3 oz PEMA C&B Pwd, very white | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 2 | H66809219601 | 0921960 | 0921960 | Qt Orig Truliner Liquid | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 3 | H66809219591 | 0921959 | 0921959 | 5 lb Orig Truliner PMMA Pwd Clear | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 4 | H66809219581 | 0921958 | 0921958 | 5 lb Orig Truliner PMMA Pwd Vein | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 5 | H66809219571 | 0921957 | 0921957 | 5 lb Orig Truliner PMMA Pwd Pink | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 6 | H66809219521 | 0921952 | 0921952 | 1 lb bulk Orig Truliner PMMA P&L Kit Vein | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 7 | H66809219511 | 0921951 | 0921951 | 1 lb bulk Orig Truliner PMMA P&L Kit Pink | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 8 | H66809219501 | 0921950 | 0921950 | Orig Truliner Liquid | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 9 | H66809219481 | 0921948 | 0921948 | Orig Truliner PMMA Pwd Vein | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 10 | H66809219471 | 0921947 | 0921947 | Orig Truliner PMMA Pwd Pink | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 11 | H66809219461 | 0921946 | 0921946 | Orig Truliner Liquid | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 12 | H66809219451 | 0921945 | 0921945 | Orig Truliner PMMA Pwd Clear | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 13 | H66809219441 | 0921944 | 0921944 | Orig Truliner PMMA Pwd Vein | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 14 | H66809219431 | 0921943 | 0921943 | Orig Truliner PMMA Pwd Pink | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 15 | H66809219421 | 0921942 | 0921942 | Orig Truliner PMMA Standard P&L Kit Clear | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 16 | H66809219411 | 0921941 | 0921941 | Orig Truliner PMMA Standard P&L Kit Vein | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 17 | H66809219401 | 0921940 | 0921940 | Orig Truliner PMMA Standard P&L Kit Pink | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth Original Truliner |
| 18 | H66809219151 | 0921915 | 0921915 | Gallon PEMA C&B Liquid | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 19 | H66809219141 | 0921914 | 0921914 | Quart PEMA C&B Liquid | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 20 | H66809219091 | 0921909 | 0921909 | 8 oz PEMA Liquid, Reg | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 21 | H66809219081 | 0921908 | 0921908 | 1 lb PEMA C&B Pwd only, Dark | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 22 | H66809219071 | 0921907 | 0921907 | 1 lb PEMA C&B Pwd only, Lt | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 23 | H66809219061 | 0921906 | 0921906 | 1 lb Trim P&L Kit, Dark Pwd | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 24 | H66809219051 | 0921905 | 0921905 | 1 lb Trim P&L Kit, Light Pwd | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 25 | H66809219031 | 0921903 | 0921903 | 6 oz PEMA C&B Liquid, Reg | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 26 | H6680921902C1 | 0921902C | 0921902C | 3 oz PEMA C&B Pwd, Clear | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 27 | H6680921902661 | 0921902-66 | 0921902-66 | 3 oz PEMA C&B Pwd, shade 66 | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 28 | H66809219021 | 0921902 | 0921902 | 3 oz PEMA C&B Pwd, dark | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 29 | H66809219011 | 0921901 | 0921901 | 3 oz PEMA C&B Pwd, light | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 30 | H6680921900L1 | 0921900L | 0921900L | PEMA Temp C&B Light Pwd Kit, 2-3 oz Pwd, 6 oz liquid | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 31 | H6680921900D1 | 0921900D | 0921900D | PEMA Temp C&B Dark Pwd Kit, 2-3 oz Pwd, 6 oz liquid | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 32 | H66809219001 | 0921900 | 0921900 | PEMA Temp C&B Standard Kit, 2-3 oz Pwd, 6 oz liquid | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 33 | H6680921751 | 092175 | 092175 | 8 oz Repair Liquid | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 34 | H66809217441 | 0921744 | 0921744 | PEMA Acrylic Impression Material 5 lb Powder | ELW | MATERIAL, IMPRESSION | 2 | Bosworth Sapphire |
| 35 | H66809217421 | 0921742 | 0921742 | PEMA Acrylic Impression Material 6 oz Liquid | ELW | MATERIAL, IMPRESSION | 2 | Bosworth Sapphire |
| 36 | H6680921741C1 | 0921741C | 0921741C | PEMA Acrylic Impression Material 8 oz Powder Clear | ELW | MATERIAL, IMPRESSION | 2 | Bosworth Sapphire |
| 37 | H66809217411 | 0921741 | 0921741 | PEMA Acrylic Impression Material 8 oz Powder Blue | ELW | MATERIAL, IMPRESSION | 2 | Bosworth Sapphire |
| 38 | H6680921740C1 | 0921740C | 0921740C | PEMA P&L Acrylic Impression Material Kit, Clear | ELW | MATERIAL, IMPRESSION | 2 | Bosworth Sapphire |
| 39 | H66809217401 | 0921740 | 0921740 | PEMA P&L Acrylic Impression Material Kit, Blue | ELW | MATERIAL, IMPRESSION | 2 | Bosworth Sapphire |
| 40 | H6680921721 | 092172 | 092172 | 1 lb Repair Pwd, Pink | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 41 | H6680921711 | 092171 | 092171 | 1 Qt Repair Liquid | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 42 | H6680921691 | 092169 | 092169 | 5 lb Repair Pwd, Vein | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 43 | H6680921641 | 092164 | 092164 | 4 oz Repair Liquid | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 44 | H6680921631 | 092163 | 092163 | 3 oz Repair Pwd, Clear | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 45 | H6680921621 | 092162 | 092162 | 3 oz Repair Pwd, Vein | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 46 | H6680921611 | 092161 | 092161 | 3 oz Repair Pwd, Pink | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 47 | H668092160V1 | 092160V | 092160V | Acrylic Repair Kit, 2-3 oz Pwd, 4 oz liquid, Veined | EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 2 | Bosworth TruRepair |
| 48 | H66809215971 | 0921597 | 0921597 | Sample PEMA Temp C&B P&L Kit, single dose | EBG | CROWN AND BRIDGE, TEMPORARY, RESIN | 2 | Bosworth Trim |
| 49 | H66809210131 | 0921013 | 0921013 | 2 oz ZOE Cement Pwd, Reg | EMA | CEMENT, DENTAL | 2 | Bosworth SuperEBA |
| 50 | H66809214071 | 0921407 | 0921407 | Fastray LC Standard Kit White | ELW | MATERIAL, IMPRESSION | Bosworth Fastray LC |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | |
| 2 | 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 | |
| 3 | 08800026400103 | NS017T | Product Name: Heavy Body Tube | PEAKOSIL | NEOSIL CO., LTD | |
| 4 | 08800026400097 | NS033CF | Product Name:PEAKOSIL Light Body Fast Set | PEAKOSIL | NEOSIL CO., LTD | |
| 5 | 08800026400080 | NS017CF | Product Name:PEAKOSIL Heavy Body Fast Set | PEAKOSIL | NEOSIL CO., LTD | |
| 6 | 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 | |
| 7 | 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 | |
| 8 | 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 | |
| 9 | 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 | |
| 10 | 08800026400028 | MSRC | Product Name: PEAKOSIL Monophase Regular SetThis product has another model number, NS024C. | PEAKOSIL | NEOSIL CO., LTD | |
| 11 | 08800026400011 | NS033C | Product Name:PEAKOSIL Light Body Regular Set | PEAKOSIL | NEOSIL CO., LTD | |
| 12 | 08800026400004 | NS017C | Product Name: PEAKOSIL Heavy Body Regular Set | PEAKOSIL | NEOSIL CO., LTD | |
| 13 | 08800024204222 | Delikit Biggg Heavy Body(75ml* 2 Cartridges) | Delikit Biggg Heavy Body | SHERPAKOREA | ||
| 14 | 08800024203997 | Delikit 3.0 Light Body Fast(4.5ml*25Cartridges) | Delikit 3.0 Light Body Fast | SHERPAKOREA | ||
| 15 | 08800024203805 | Delikit 3.0 Light Body(4.5ml* 25 Cartridges) | Delikit 3.0 Light Body | SHERPAKOREA | ||
| 16 | 08800024203294 | Deli-Border (50ml * 2 Cartridges) | Deli-Border | SHERPAKOREA | ||
| 17 | 08800024203287 | Delikit Heavy Body fast (50ml * 2 Cartridges) | Delikit Heavy Body FS | SHERPAKOREA | ||
| 18 | 08800024203270 | Delikit Light Body fast (50ml * 2 Cartridges) | Delikit Light Body FS | SHERPAKOREA | ||
| 19 | 08800024203263 | Delikit 200 Heavy Body (200ml * 3 Cartridges) | Delikit 200 Heavy Body | SHERPAKOREA | ||
| 20 | 08800024203249 | Densurefit (2.4ml * 720 Cartridges) | Densurefit | SHERPAKOREA | ||
| 21 | 08800024203232 | Delikit Bite Registration (50ml * 10 Cartridges) | Delikit Bite Registration | SHERPAKOREA | ||
| 22 | 08800024203225 | Delikit Light Body fast (50ml * 10 Cartridges) | Delikit Light Body FS | SHERPAKOREA | ||
| 23 | 08800024203218 | Delikit Light Body (50ml * 10 Cartridges) | Delikit Light Body | SHERPAKOREA | ||
| 24 | 08800024203201 | Delikit Medium Body (50ml * 10 Cartridges) | Delikit Medium Body | SHERPAKOREA | ||
| 25 | 08800024203195 | Delikit Heavy Body Fast (50ml * 10 Cartridges) | Delikit Heavy Body FS | SHERPAKOREA | ||
| 26 | 08800024203188 | Delikit Heavy Body (50ml * 10 Cartridges) | Delikit Heavy Body | SHERPAKOREA | ||
| 27 | 08800024203171 | Jackpot Bite (10ml * 100 Cartridges) | Jackpot Bite | SHERPAKOREA | ||
| 28 | 08800024203164 | Jackpot Light Body (10ml * 75 Cartridges) | Jackpot Light Body | SHERPAKOREA | ||
| 29 | 08800024203119 | Densurefit (2.4ml * 708 Cartridges) | Densurefit | SHERPAKOREA | ||
| 30 | 08800024203102 | Jackpot Light Body Fast (10ml * 10 Cartridges) | Jackpot Light Body Fast | SHERPAKOREA | ||
| 31 | 08800024203096 | Jackpot Light Body Fast (10ml * 4 Cartridges) | Jackpot Light Body Fast | SHERPAKOREA | ||
| 32 | 08800024203089 | Jackpot Light Body (10ml * 10 Cartridges) | Jackpot Light Body | SHERPAKOREA | ||
| 33 | 08800024203072 | Jackpot Light Body (10ml * 4 Cartridges) | Jackpot Light Body | SHERPAKOREA | ||
| 34 | 08800024203065 | Jackpot Bite (10ml * 10 Cartridges) | Jackpot Bite | SHERPAKOREA | ||
| 35 | 08800024203058 | Jackpot Bite (10ml * 4 Cartridges) | Jackpot Bite | SHERPAKOREA | ||
| 36 | 08800024203041 | Jackpot Light Body Fast (10ml * 25 Cartridges) | Jackpot Light Body Fast | SHERPAKOREA | ||
| 37 | 08800024203027 | Jackpot Bite (10ml * 50 Cartridges) | Jackpot Bite | SHERPAKOREA | ||
| 38 | 08800024203010 | Jackpot Light Body Fast (10ml * 100 Cartridges) | Jackpot Light Body Fast | SHERPAKOREA | ||
| 39 | 08800024203003 | Jackpot Light Body (10ml * 100 Cartridges) | Jackpot Light Body | SHERPAKOREA | ||
| 40 | 08800024202990 | Jackpot Light Body (10ml * 25 Cartridges) | Jackpot Light Body | SHERPAKOREA | ||
| 41 | 08800024202983 | Deli-Big (360ml * 2 Cartridges) | Deli Big | SHERPAKOREA | ||
| 42 | 08800024202976 | Vaccusil Bite Registration (50ml * 4 Cartridges) | Vaccusil Bite Registration | SHERPAKOREA | ||
| 43 | 08800024202969 | Delikit Extra Light Body (50ml * 4 Cartridges) | Delikit Extra Light Body | SHERPAKOREA | ||
| 44 | 08800024202952 | Delikit Medium Body (50ml * 4 Cartridges) | Delikit Medium Body | SHERPAKOREA | ||
| 45 | 08800024201948 | Precisil Big (390ml * 2Cartridges) | Precisil Big | SHERPAKOREA | ||
| 46 | 08800024201931 | Delikit Premium Light Body (50ml * 50 Cartridges) | Delikit Premium Light Body | SHERPAKOREA | ||
| 47 | 08800024201924 | Precisil Heavy Body fast (50ml * 4 Cartridges) | Precisil Heavy Body FS | SHERPAKOREA | ||
| 48 | 08800024201917 | Delikit Light Body fast (50ml * 4 Cartridges) | Delikit Light Body FS | SHERPAKOREA | ||
| 49 | 08800024201900 | Delikit Light Body (50ml * 4 Cartridges) | Delikit Light Body | SHERPAKOREA | ||
| 50 | 08800024201894 | Delikit Bite Registration (50ml * 4 Cartridges) | Delikit Bite Registration | SHERPAKOREA |