Henry Schein
OBTURATOR - VUL6 - SIZE 45 VC Obt 6pk - VCC 4.5
42manufacturers in China registered for this device type
386catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Shanghai (8), Jiangsu (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Dentsply Dental (Tianjin) Co., Ltd. | Teda | Tianjin | Contract manufacturer | 2 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
Showing 12 of 42. All 42 manufacturers in China registered for Gutta-Percha
Record
| Listed by | Henry Schein, Inc., United States |
|---|---|
| FDA product code | EKM |
| Device type | Gutta-Percha |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3850 |
| Premarket notification | Exempt |
| Record published | 2021-01-28 |
| Record revised | 2020-08-25 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1007229 | 100 | In distribution | |
| 1045244 | 100 | In distribution | |
| 2020327 | 6 | In distribution | |
| 2020321 | 20 | In distribution | |
| 2020334 | 20 | In distribution | |
| 1005964 | 100 | In distribution | |
| 1002981 | 100 | In distribution | |
| 1006571 | 150 | In distribution | |
| 1014220 | 120 | In distribution | |
| 1012310 | 120 | In distribution | |
| 2020332 | 20 | In distribution | |
| 1042556 | 100 | In distribution | |
| 1002132 | 100 | In distribution | |
| 1009683 | 100 | In distribution | |
| 1014186 | 120 | In distribution | |
| 1014429 | 150 | In distribution | |
| 1013804 | 120 | In distribution | |
| 5703308 | 100 | In distribution | |
| 1017594 | 6 | In distribution | |
| 2020339 | 50 | In distribution | |
| 1009997 | In distribution | ||
| 1016003 | 6 | In distribution | |
| 1018247 | 120 | In distribution | |
| 1018817 | 120 | In distribution | |
| 1012096 | 6 | In distribution | |
| 1015123 | 120 | In distribution | |
| 1014186 | 120 | In distribution | |
| 1001746 | 50 | In distribution | |
| 1017594 | 120 | In distribution | |
| 1045317 | 100 | In distribution | |
| 1000429 | 100 | In distribution | |
| 1048053 | 100 | In distribution | |
| 1009012 | 100 | In distribution | |
| 1000548 | 50 | In distribution | |
| 1004903 | 50 | In distribution | |
| 1011842 | 120 | In distribution | |
| 1012096 | 120 | In distribution | |
| 1010370 | 120 | In distribution | |
| 1012613 | 120 | In distribution | |
| 1045317 | 100 | In distribution | |
| 1049720 | 100 | In distribution | |
| 1045781 | 100 | In distribution | |
| 1003894 | 150 | In distribution | |
| 1009683 | 150 | In distribution | |
| 1007554 | 30 | In distribution | |
| 1016628 | 120 | In distribution | |
| 1043428 | 100 | In distribution | |
| 1005828 | 100 | In distribution | |
| 2020330 | 20 | In distribution | |
| 1018247 | 6 | In distribution | |
| 1005310 | 100 | In distribution | |
| 1002086 | 100 | In distribution | |
| 5703317 | 100 | In distribution | |
| 1003392 | 150 | In distribution | |
| 1012613 | 6 | In distribution | |
| 5703309 | 100 | In distribution | |
| 1010370 | 120 | In distribution | |
| 5703326 | 100 | In distribution | |
| 1008906 | 100 | In distribution | |
| 1011179 | 120 | In distribution | |
| 1000527 | 100 | In distribution | |
| 1000057 | In distribution | ||
| 5703306 | 100 | In distribution | |
| 1000527 | 100 | In distribution | |
| 1007831 | 100 | In distribution | |
| 1043504 | 100 | In distribution | |
| 1007740 | 50 | In distribution | |
| 2020307 | 6 | In distribution | |
| 1012875 | 120 | In distribution | |
| 1014539 | 120 | In distribution | |
| 1007592 | 100 | In distribution | |
| 1005565 | 50 | In distribution | |
| 1048212 | 100 | In distribution | |
| 1007107 | 100 | In distribution | |
| 1006649 | 100 | In distribution | |
| 1015375 | 120 | In distribution | |
| 1008393 | 240 | In distribution | |
| 1006959 | 100 | In distribution | |
| 5703329 | 100 | In distribution | |
| 1008393 | In distribution | ||
| 2020311 | 6 | In distribution | |
| 1015072 | 120 | In distribution | |
| 1045781 | 100 | In distribution | |
| 1007341 | 100 | In distribution | |
| 1015072 | 6 | In distribution | |
| 1011179 | 6 | In distribution | |
| 1006911 | 150 | In distribution | |
| 2020328 | 6 | In distribution | |
| 1012613 | 120 | In distribution | |
| 2020333 | 20 | In distribution | |
| 1008504 | 150 | In distribution | |
| 1042556 | 100 | In distribution | |
| 1015122 | 120 | In distribution | |
| 1003115 | 100 | In distribution | |
| 1001702 | 150 | In distribution | |
| 1000618 | 30 | In distribution | |
| 1000066 | 100 | In distribution | |
| 2020320 | 20 | In distribution | |
| 1005338 | 50 | In distribution | |
| 1006026 | 100 | In distribution | |
| 1046500 | 100 | In distribution | |
| 1000172 | 50 | In distribution | |
| 1046399 | 100 | In distribution | |
| 1016628 | 120 | In distribution | |
| 2020316 | 20 | In distribution | |
| 1015375 | 120 | In distribution | |
| 1002705 | 150 | In distribution | |
| 1006174 | 100 | In distribution | |
| 1015375 | 120 | In distribution | |
| 1006911 | 100 | In distribution | |
| 1001666 | 100 | In distribution | |
| 1013570 | 120 | In distribution | |
| 1006796 | 100 | In distribution | |
| 1013956 | 6 | In distribution | |
| 1018688 | 120 | In distribution | |
| 1011855 | 120 | In distribution | |
| 2020338 | 50 | In distribution | |
| 1003428 | 100 | In distribution | |
| 1014220 | 120 | In distribution | |
| 1049720 | 100 | In distribution | |
| 1013803 | 120 | In distribution | |
| 1018817 | 120 | In distribution | |
| 1014539 | 120 | In distribution | |
| 2020314 | 6 | In distribution | |
| 1018674 | 6 | In distribution | |
| 2020323 | 6 | In distribution | |
| 1006571 | 150 | In distribution | |
| 1043428 | 100 | In distribution | |
| 1012919 | 120 | In distribution | |
| 2020325 | 6 | In distribution | |
| 1000020 | 100 | In distribution | |
| 1010605 | 120 | In distribution | |
| 1010605 | 120 | In distribution | |
| 1017740 | 120 | In distribution | |
| 1012452 | 120 | In distribution | |
| 2020310 | 6 | In distribution | |
| 1047974 | 100 | In distribution | |
| 1002705 | 100 | In distribution | |
| 1047954 | 100 | In distribution | |
| 2020340 | 50 | In distribution | |
| 1042576 | 100 | In distribution | |
| 1006734 | 100 | In distribution | |
| 1011858 | 120 | In distribution | |
| 1007349 | In distribution | ||
| 2020317 | 20 | In distribution | |
| 1000429 | 100 | In distribution | |
| 1014846 | 120 | In distribution | |
| 1015630 | 120 | In distribution | |
| 1008906 | 150 | In distribution | |
| 1011855 | 120 | In distribution | |
| 1011855 | 120 | In distribution | |
| 1012096 | 120 | In distribution | |
| 1045701 | 100 | In distribution | |
| 1046399 | 100 | In distribution | |
| 5703320 | 150 | In distribution | |
| 1048053 | 100 | In distribution | |
| 1000669 | 100 | In distribution | |
| 1013803 | 120 | In distribution | |
| 1012452 | 120 | In distribution | |
| 1012452 | 6 | In distribution | |
| 1003392 | 100 | In distribution | |
| 1042558 | 100 | In distribution | |
| 1043428 | 100 | In distribution | |
| 1018528 | 120 | In distribution | |
| 2020326 | 6 | In distribution | |
| 1007229 | 150 | In distribution | |
| 1003894 | 150 | In distribution | |
| 2020312 | 6 | In distribution | |
| 1010370 | 120 | In distribution | |
| 1001286 | 100 | In distribution | |
| 5703319 | 150 | In distribution | |
| 1004216 | 100 | In distribution | |
| 1045701 | 100 | In distribution | |
| 1013514 | 120 | In distribution | |
| 1006959 | 100 | In distribution | |
| 1001286 | 100 | In distribution | |
| 1008261 | 100 | In distribution | |
| 1011858 | 6 | In distribution | |
| 1016488 | 120 | In distribution | |
| 1010363 | 120 | In distribution | |
| 1015122 | 120 | In distribution | |
| 1018817 | 120 | In distribution | |
| 2020316 | 20 | In distribution | |
| 2020318 | 20 | In distribution | |
| 1013864 | 120 | In distribution | |
| 1001702 | 100 | In distribution | |
| 5703316 | 100 | In distribution | |
| 1047974 | 100 | In distribution | |
| 1004216 | 100 | In distribution | |
| 2020350 | 6 | In distribution | |
| 1007341 | 150 | In distribution | |
| 1046399 | 100 | In distribution | |
| 1014846 | 120 | In distribution | |
| 1015143 | 120 | In distribution | |
| 1016560 | 120 | In distribution | |
| 1008261 | 150 | In distribution | |
| 1011179 | 120 | In distribution | |
| 2020335 | 20 | In distribution | |
| 2020330 | 20 | In distribution | |
| 2020346 | 6 | In distribution | |
| 5703325 | 100 | In distribution | |
| 1003115 | 150 | In distribution | |
| 5703310 | 100 | In distribution | |
| 1045701 | 100 | In distribution | |
| 1042558 | 100 | In distribution | |
| 1015630 | 6 | In distribution | |
| 1015072 | 120 | In distribution | |
| 1007948 | 50 | In distribution | |
| 1001871 | In distribution | ||
| 1015833 | 120 | In distribution | |
| 1006279 | In distribution | ||
| 1049720 | 100 | In distribution | |
| 2020336 | 50 | In distribution | |
| 1045781 | 100 | In distribution | |
| 5703312 | 100 | In distribution | |
| 5703315 | 100 | In distribution | |
| 1003392 | 100 | In distribution | |
| 1013804 | 120 | In distribution | |
| 1007017 | 50 | In distribution | |
| 1019488 | 120 | In distribution | |
| 1046500 | 100 | In distribution | |
| 1016488 | 120 | In distribution | |
| 1018247 | 120 | In distribution | |
| 1011842 | 120 | In distribution | |
| 1016560 | 120 | In distribution | |
| 1013570 | 120 | In distribution | |
| 5703318 | 100 | In distribution | |
| 1047974 | 100 | In distribution | |
| 1012310 | 6 | In distribution | |
| 1014444 | 6 | In distribution | |
| 1048053 | 100 | In distribution | |
| 1002302 | 100 | In distribution | |
| 1008261 | 100 | In distribution | |
| 1008504 | 150 | In distribution | |
| 1006959 | 150 | In distribution | |
| 1006748 | 100 | In distribution | |
| 1018528 | 6 | In distribution | |
| 1016003 | 120 | In distribution | |
| 1046500 | 100 | In distribution | |
| 1003893 | 100 | In distribution | |
| 1007107 | 100 | In distribution | |
| 1003893 | 150 | In distribution | |
| 5703328 | 100 | In distribution | |
| 1013804 | 120 | In distribution | |
| 1018688 | 120 | In distribution | |
| 1045244 | 100 | In distribution | |
| 2020309 | 6 | In distribution | |
| 1003894 | 150 | In distribution | |
| 2020318 | 20 | In distribution | |
| 5703307 | 100 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gutta Percha Points | Diadent Group Intl., Inc. | 1,404 |
| MM Marked Gutta Percha Points | Diadent Group Intl., Inc. | 683 |
| Zarc | Shanghai Xing YU Medical Equipment Co., Ltd. | 166 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 130 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 126 |
| Avalon Biomed | Shanghai Xing YU Medical Equipment Co., Ltd. | 106 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 97 |
| Safco gutta percha points | Safco Dental Supply | 90 |
| Sure-endo | Sure Dent Corporation | 89 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 82 |
| Endodontic Obturators | Tulsa Dental Products LLC | 78 |
| Midway Select | Midway Dental Supply, LLC | 70 |
Showing 12 of 599. All products under Gutta-Percha
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.