Integra® Miltex®
Precise™ Gutta Percha Points, Accessory XF-M-120/PK
42manufacturers in China registered for this device type
67catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKM |
| Device type | Gutta-Percha |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3850 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-16 |
| Record revised | 2022-07-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Away From Sunlight |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 017-51241M | 60 | Withdrawn | |
| 700-228 | 100 | Withdrawn | |
| 017-51222M | 100 | Withdrawn | |
| 017-51263 | 100 | Withdrawn | |
| 017-51244M | 60 | Withdrawn | |
| 700-504 | 60 | Withdrawn | |
| 017-51230M | 100 | Withdrawn | |
| 017-51261 | 100 | Withdrawn | |
| 017-51206M | 120 | Withdrawn | |
| 700-433 | Withdrawn | ||
| 700-1027 | 120 | Withdrawn | |
| 017-51224M | 100 | Withdrawn | |
| 700-505 | 60 | Withdrawn | |
| 017-51225M | 100 | Withdrawn | |
| 700-229 | 100 | Withdrawn | |
| 017-51248M | Withdrawn | ||
| 017-51221M | 100 | Withdrawn | |
| 700-429 | 120 | Withdrawn | |
| 017-51213M | Withdrawn | ||
| 700-1028 | 120 | Withdrawn | |
| 017-51262 | 100 | Withdrawn | |
| 017-51228M | 100 | Withdrawn | |
| 017-51264 | 100 | Withdrawn | |
| 017-51245M | 60 | Withdrawn | |
| 700-523 | 60 | Withdrawn | |
| 017-51212M | Withdrawn | ||
| 017-51223M | 100 | Withdrawn | |
| 017-51214M | Withdrawn | ||
| 700-422 | Withdrawn | ||
| 017-51226M | 100 | Withdrawn | |
| 017-51204M | 120 | Withdrawn | |
| 017-51243M | 60 | Withdrawn | |
| 700-528 | Withdrawn | ||
| 700-513 | Withdrawn | ||
| 700-425 | 120 | Withdrawn | |
| 700-424 | 120 | Withdrawn | |
| 017-51209M | 120 | Withdrawn | |
| 017-51260 | 100 | Withdrawn | |
| 700-501 | 60 | Withdrawn | |
| 700-502 | 60 | Withdrawn | |
| 700-1026 | 120 | Withdrawn | |
| 700-503 | 60 | Withdrawn | |
| 017-51220M | 100 | Withdrawn | |
| 700-428 | 120 | Withdrawn | |
| 017-51207M | 120 | Withdrawn | |
| 700-1014 | 120 | Withdrawn | |
| 017-51240M | 60 | Withdrawn | |
| 700-727 | Withdrawn | ||
| 700-1029 | 120 | Withdrawn | |
| 017-51227M | 100 | Withdrawn | |
| 700-524 | 60 | Withdrawn | |
| 700-1013 | 120 | Withdrawn | |
| 017-51205M | 120 | Withdrawn | |
| 017-51265 | 100 | Withdrawn | |
| 017-51201M | 120 | Withdrawn | |
| 017-51242M | 60 | Withdrawn | |
| 700-1025 | 120 | Withdrawn | |
| 017-51200M | 120 | Withdrawn | |
| 700-526 | 60 | Withdrawn | |
| 017-51203M | 120 | Withdrawn | |
| 017-51266 | Withdrawn | ||
| 700-1023 | Withdrawn | ||
| 700-426 | 120 | Withdrawn | |
| 017-51210M | 120 | Withdrawn | |
| 017-51202M | 120 | Withdrawn | |
| 700-517 | 60 | Withdrawn | |
| 017-51229M | 100 | Withdrawn |
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.