Darby Dental Supply, LLC
Gutta Percha Points Deluxe #45-80 Vials
42manufacturers in China registered for this device type
130catalogue 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 | Darby Dental Supply, LLC |
|---|---|
| FDA product code | EKM |
| Device type | Gutta-Percha |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3850 |
| Premarket notification | Exempt |
| Record published | 2021-02-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9514337 | 120 | In distribution | |
| 9514306 | 120 | In distribution | |
| 9510948 | 6 | In distribution | |
| 9510932 | 6 | In distribution | |
| 9514209 | 100 | In distribution | |
| 9514310 | 120 | In distribution | |
| 9510950 | 6 | In distribution | |
| 9510952 | 6 | In distribution | |
| 9514277 | 120 | In distribution | |
| 9514306 | 120 | In distribution | |
| 9514208 | 100 | In distribution | |
| 9514280 | 120 | In distribution | |
| 9514333 | 120 | In distribution | |
| 9514315 | 120 | In distribution | |
| 9514304 | 120 | In distribution | |
| 9510949 | 6 | In distribution | |
| 9510965 | 6 | In distribution | |
| 9514315 | 120 | In distribution | |
| 9510958 | 6 | In distribution | |
| 9514338 | 120 | In distribution | |
| 9514344 | 120 | In distribution | |
| 9514274 | 120 | In distribution | |
| 9514204 | 100 | In distribution | |
| 9514332 | 120 | In distribution | |
| 9510944 | 6 | In distribution | |
| 9514335 | 120 | In distribution | |
| 9510968 | 6 | In distribution | |
| 9514352 | 120 | In distribution | |
| 9514288 | 120 | In distribution | |
| 9514277 | 120 | In distribution | |
| 9514200 | 100 | In distribution | |
| 9514276 | 120 | In distribution | |
| 9514271 | 120 | In distribution | |
| 9514334 | 120 | In distribution | |
| 9514278 | 120 | In distribution | |
| 9514276 | 120 | In distribution | |
| 9510962 | 6 | In distribution | |
| 9514204 | 100 | In distribution | |
| 9510941 | 6 | In distribution | |
| 9514340 | 120 | In distribution | |
| 9514300 | 120 | In distribution | |
| 9514206 | 100 | In distribution | |
| 9510937 | 6 | In distribution | |
| 9510951 | 6 | In distribution | |
| 9514212 | 100 | In distribution | |
| 9510960 | 6 | In distribution | |
| 9514200 | 100 | In distribution | |
| 9514270 | 120 | In distribution | |
| 9510943 | 6 | In distribution | |
| 9514334 | 120 | In distribution | |
| 9514343 | 120 | In distribution | |
| 9510940 | 6 | In distribution | |
| 9510973 | 6 | In distribution | |
| 9510953 | 6 | In distribution | |
| 9514273 | 120 | In distribution | |
| 9514335 | 120 | In distribution | |
| 9510963 | 6 | In distribution | |
| 9514206 | 100 | In distribution | |
| 9514275 | 120 | In distribution | |
| 9510954 | 6 | In distribution | |
| 9510969 | 6 | In distribution | |
| 9514270 | 120 | In distribution | |
| 9514337 | 120 | In distribution | |
| 9514279 | 120 | In distribution | |
| 9514289 | 120 | In distribution | |
| 9514275 | 120 | In distribution | |
| 9514302 | 120 | In distribution | |
| 9510972 | 6 | In distribution | |
| 9514202 | 100 | In distribution | |
| 9510964 | 6 | In distribution | |
| 9514202 | 100 | In distribution | |
| 9510945 | 6 | In distribution | |
| 9514352 | 120 | In distribution | |
| 9510971 | 6 | In distribution | |
| 9514339 | 120 | In distribution | |
| 9510942 | 6 | In distribution | |
| 9514281 | 120 | In distribution | |
| 9510947 | 6 | In distribution | |
| 9514274 | 120 | In distribution | |
| 9514304 | 120 | In distribution | |
| 9514331 | 120 | In distribution | |
| 9510959 | 6 | In distribution | |
| 9514341 | 120 | In distribution | |
| 9510939 | 6 | In distribution | |
| 9510970 | 6 | In distribution | |
| 9510957 | 6 | In distribution | |
| 9510967 | 6 | In distribution | |
| 9514288 | 120 | In distribution | |
| 9514271 | 120 | In distribution | |
| 9510938 | 6 | In distribution | |
| 9510956 | 6 | In distribution | |
| 9514341 | 120 | In distribution | |
| 9514281 | 120 | In distribution | |
| 9514312 | 120 | In distribution | |
| 9514344 | 120 | In distribution | |
| 9514212 | 100 | In distribution | |
| 9514209 | 100 | In distribution | |
| 9514331 | 120 | In distribution | |
| 9514343 | 120 | In distribution | |
| 9510946 | 6 | In distribution | |
| 9514308 | 120 | In distribution | |
| 9510934 | 6 | In distribution | |
| 9514336 | 120 | In distribution | |
| 9514289 | 120 | In distribution | |
| 9514272 | 120 | In distribution | |
| 9514272 | 120 | In distribution | |
| 9514302 | 120 | In distribution | |
| 9510936 | 6 | In distribution | |
| 9514340 | 120 | In distribution | |
| 9510935 | 6 | In distribution | |
| 9514308 | 120 | In distribution | |
| 9514330 | 120 | In distribution | |
| 9514330 | 120 | In distribution | |
| 9510961 | 6 | In distribution | |
| 9514280 | 120 | In distribution | |
| 9514279 | 120 | In distribution | |
| 9514278 | 120 | In distribution | |
| 9514273 | 120 | In distribution | |
| 9510966 | 6 | In distribution | |
| 9514312 | 120 | In distribution | |
| 9514310 | 120 | In distribution | |
| 9510933 | 6 | In distribution | |
| 9514332 | 120 | In distribution | |
| 9514336 | 120 | In distribution | |
| 9514300 | 120 | In distribution | |
| 9510955 | 6 | In distribution | |
| 9514208 | 100 | In distribution | |
| 9514338 | 120 | In distribution | |
| 9514339 | 120 | In distribution | |
| 9514333 | 120 | In distribution |
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 |
| Henry Schein | Henry Schein, Inc. | 386 |
| Zarc | Shanghai Xing YU Medical Equipment Co., Ltd. | 166 |
| 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.