Hygenic® Guttapercha Points
HYGENIC® Guttapercha Points Top color ISO 90 - 140
42manufacturers in China registered for this device type
36catalogue 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 | Coltène/Whaledent AG, Switzerland |
|---|---|
| FDA product code | EKM |
| Device type | Gutta-Percha |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3850 |
| Premarket notification | Exempt |
| Record published | 2022-09-22 |
| Record revised | 2025-01-10 (version 2) |
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 |
| Storage | Special storage condition: keep dry; Special storage condition: keep away from sunlight; Storage environment temperature up to 25 °C; Storage environment temperature up to 77 °F |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H01472 | 100 | In distribution | |
| H01221 | 100 | In distribution | |
| H01478 | 100 | In distribution | |
| H01469 | 100 | In distribution | |
| 60026846 | In distribution | ||
| H01480 | 100 | In distribution | |
| H01224 | 100 | In distribution | |
| H04230 | 100 | In distribution | |
| H01226 | 100 | In distribution | |
| H01223 | 100 | In distribution | |
| H01476 | 100 | In distribution | |
| H04234 | 100 | In distribution | |
| H01225 | 100 | In distribution | |
| H01474 | 100 | In distribution | |
| H01484 | 100 | In distribution | |
| H01477 | 100 | In distribution | |
| H01483 | 100 | In distribution | |
| H04232 | 100 | In distribution | |
| H01485 | 100 | In distribution | |
| H01306 | 100 | In distribution | |
| H04233 | 100 | In distribution | |
| H04229 | 100 | In distribution | |
| H01475 | 100 | In distribution | |
| 60026845 | In distribution | ||
| H01304 | 100 | In distribution | |
| H01305 | 100 | In distribution | |
| H01471 | 100 | In distribution | |
| H01473 | 100 | In distribution | |
| H01479 | 100 | In distribution | |
| H01222 | 100 | In distribution | |
| H04231 | 100 | In distribution | |
| 60026844 | In distribution | ||
| H01470 | 100 | In distribution | |
| H01486 | 100 | In distribution | |
| H01482 | 100 | In distribution | |
| H01481 | 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 |
| Sure-endo | Sure Dent Corporation | 89 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 82 |
| Endodontic Obturators | Tulsa Dental Products LLC | 78 |
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.