Sure-Endo
Bio Gutta Percha Points Taper .05, Size 15-40, 60/PK, mm marked, SB
42manufacturers in China registered for this device type
89catalogue 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 | Sure Dent Corporation, South Korea |
|---|---|
| FDA product code | EKM |
| Device type | Gutta-Percha |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3850 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-10 |
| Record revised | 2025-02-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a cool area and avoid exposure to sunlight |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10002002 | 120 | In distribution | |
| 10014002 | 120 | In distribution | |
| G906 LB35.05 | 60 | In distribution | |
| 10002004 | 60 | In distribution | |
| G906 B10F45.04 | 60 | In distribution | |
| G906 LB45.05 | 60 | In distribution | |
| G906 B10F45.06 | 60 | In distribution | |
| 10005506 | 60 | In distribution | |
| 10458006 | 60 | In distribution | |
| 10004504 | 60 | In distribution | |
| 10003502 | 120 | In distribution | |
| 10002504 | 60 | In distribution | |
| 10010002 | 120 | In distribution | |
| 10000HAR | 100 | In distribution | |
| 10008004 | 60 | In distribution | |
| G906 B10F50.06 | 60 | In distribution | |
| 10004506 | 60 | In distribution | |
| 100F4500 | 60 | In distribution | |
| 10000REG | 100 | In distribution | |
| 10006004 | 60 | In distribution | |
| 10001002 | 120 | In distribution | |
| 10006002 | 120 | In distribution | |
| 10458004 | 60 | In distribution | |
| G906 LB15.05 | 60 | In distribution | |
| 10003006 | 60 | In distribution | |
| G906 B10F20.04 | 60 | In distribution | |
| 1000F200 | 60 | In distribution | |
| 10005502 | 120 | In distribution | |
| 10005002 | 120 | In distribution | |
| 10000SOF | 100 | In distribution | |
| 10000802 | 120 | In distribution | |
| 10007002 | 120 | In distribution | |
| G906 B10F40.04 | 60 | In distribution | |
| 10001506 | 60 | In distribution | |
| G906 LB40.05 | 60 | In distribution | |
| 1000F100 | 60 | In distribution | |
| 10002502 | 120 | In distribution | |
| 10002506 | 60 | In distribution | |
| G906 LB25.05 | 60 | In distribution | |
| 10008002 | 120 | In distribution | |
| 10003004 | 60 | In distribution | |
| G906 B10F35.06 | 60 | In distribution | |
| 10004502 | 120 | In distribution | |
| 10008006 | 60 | In distribution | |
| 10005004 | 60 | In distribution | |
| 1000F300 | 60 | In distribution | |
| G906 B10F30.04 | 60 | In distribution | |
| 10154002 | 120 | In distribution | |
| 10003506 | 60 | In distribution | |
| G906 B10F25.04 | 60 | In distribution | |
| 10003504 | 60 | In distribution | |
| 10003002 | 120 | In distribution | |
| G906 B10F15.06 | 60 | In distribution | |
| 10011002 | 120 | In distribution | |
| 10009002 | 120 | In distribution | |
| G906 B10F55.04 | 60 | In distribution | |
| 10005504 | 60 | In distribution | |
| G906 B10F55.06 | 60 | In distribution | |
| 10004006 | 60 | In distribution | |
| 10012002 | 120 | In distribution | |
| G906 B10F60.06 | 60 | In distribution | |
| G906 B10F25.06 | 60 | In distribution | |
| 10204506 | 60 | In distribution | |
| 10F12300 | 60 | In distribution | |
| 1000F400 | 60 | In distribution | |
| G906 LB20.05 | 60 | In distribution | |
| G906 B10F15.04 | 60 | In distribution | |
| G906 LB15-40/.05 | 60 | In distribution | |
| 10458002 | 120 | In distribution | |
| 10002006 | 60 | In distribution | |
| 10204504 | 60 | In distribution | |
| G906 B10F20.06 | 60 | In distribution | |
| G906 B10F40.06 | 60 | In distribution | |
| 10001502 | 120 | In distribution | |
| G906 B10F30.06 | 60 | In distribution | |
| G906 B10F35.04 | 60 | In distribution | |
| 10004002 | 120 | In distribution | |
| 10013002 | 120 | In distribution | |
| 10007006 | 60 | In distribution | |
| 10007004 | 60 | In distribution | |
| 10006006 | 60 | In distribution | |
| G906 LB30.05 | 60 | In distribution | |
| G906 B10F50.04 | 60 | In distribution | |
| 10001504 | 60 | In distribution | |
| 1000F500 | 60 | In distribution | |
| 19014002 | 120 | In distribution | |
| 10004004 | 60 | In distribution | |
| 10005006 | 60 | In distribution | |
| Hard | 100 | 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 |
| 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 |
| 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.