Endodontic Hand Instruments
Unifile hand file Maillefer North America
53manufacturers in China registered for this device type
612catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (13), Jiangsu (8), Shanghai (7). 9 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Wuhu Guli Ortho Co., Ltd. | Wuhu | Anhui | Contract manufacturer | 12 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
| Zhejiang Eksen Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 9 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
Showing 12 of 53. All 53 manufacturers in China registered for File, Pulp Canal, Endodontic
Record
| Listed by | Tulsa Dental Products LLC, United States |
|---|---|
| FDA product code | EKS |
| Device type | File, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-11-19 |
| Record revised | 2025-12-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6853531 | 6 | In distribution | |
| 82331165 | 6 | In distribution | |
| 671104 | 6 | In distribution | |
| 7331040 | 6 | In distribution | |
| 6857021 | 6 | In distribution | |
| 671107 | 6 | In distribution | |
| 86321030 | 6 | In distribution | |
| 86325025 | 6 | In distribution | |
| 6848021 | 6 | In distribution | |
| 6331055 | 6 | In distribution | |
| 87331080 | 6 | In distribution | |
| 6845525 | 6 | In distribution | |
| 6325006 | 6 | In distribution | |
| 87321045 | 6 | In distribution | |
| 6421035 | 6 | In distribution | |
| 671138 | 6 | In distribution | |
| 6844031 | 6 | In distribution | |
| 6860621 | 6 | In distribution | |
| 671161 | 6 | In distribution | |
| 86321050 | 6 | In distribution | |
| 6843031 | 6 | In distribution | |
| 86321008 | 6 | In distribution | |
| 668742 | In distribution | ||
| 6321165 | 6 | In distribution | |
| 82331010 | 6 | In distribution | |
| 6842521 | 6 | In distribution | |
| 668723 | In distribution | ||
| 6700825 | 6 | In distribution | |
| 668711 | In distribution | ||
| 6862525 | 6 | In distribution | |
| 86321045 | 6 | In distribution | |
| 87325165 | 6 | In distribution | |
| 671105 | 6 | In distribution | |
| 7331170 | 6 | In distribution | |
| 6521006 | 6 | In distribution | |
| 82431040 | 6 | In distribution | |
| 7321030 | 6 | In distribution | |
| 671110 | 6 | In distribution | |
| 86425160 | 6 | In distribution | |
| 87325070 | 6 | In distribution | |
| 26325020 | 6 | In distribution | |
| 6331175 | 6 | In distribution | |
| 6331020 | 6 | In distribution | |
| 82321055 | 6 | In distribution | |
| 82321050 | 6 | In distribution | |
| 6701021 | 6 | In distribution | |
| 82319008 | 6 | In distribution | |
| 87321008 | 6 | In distribution | |
| 82321035 | 6 | In distribution | |
| 670AS25 | 6 | In distribution | |
| 82431020 | 6 | In distribution | |
| 6860625 | 6 | In distribution | |
| 7325070 | 6 | In distribution | |
| 86321006 | 6 | In distribution | |
| 87331055 | 6 | In distribution | |
| 671151 | 6 | In distribution | |
| 82331015 | 6 | In distribution | |
| 87321035 | 6 | In distribution | |
| 671103 | 6 | In distribution | |
| 86421025 | 6 | In distribution | |
| 6856031 | 6 | In distribution | |
| 6863025 | 6 | In distribution | |
| 87325025 | 6 | In distribution | |
| 6848025 | 6 | In distribution | |
| 7328030 | 6 | In distribution | |
| 82331070 | 6 | In distribution | |
| 6842525 | 6 | In distribution | |
| 6521008 | 6 | In distribution | |
| 6325030 | 6 | In distribution | |
| 86325070 | 6 | In distribution | |
| 6856025 | 6 | In distribution | |
| 6851025 | 6 | In distribution | |
| 87321040 | 6 | In distribution | |
| 86321010 | 6 | In distribution | |
| 82431030 | 6 | In distribution | |
| 668712 | In distribution | ||
| 671000 | 6 | In distribution | |
| 85325025 | 6 | In distribution | |
| 6325160 | 6 | In distribution | |
| 6845021 | 6 | In distribution | |
| 86331030 | 6 | In distribution | |
| 82331008 | 6 | In distribution | |
| 6325050 | 6 | In distribution | |
| 6855021 | 6 | In distribution | |
| 6852531 | 6 | In distribution | |
| 671163 | 6 | In distribution | |
| 82325020 | 6 | In distribution | |
| 82425160 | 6 | In distribution | |
| 2632555 | 6 | In distribution | |
| 670AS21 | 6 | In distribution | |
| 671181 | 6 | In distribution | |
| 6852031 | 6 | In distribution | |
| 671133 | 6 | In distribution | |
| 86325020 | 6 | In distribution | |
| 87331040 | 6 | In distribution | |
| 6331050 | 6 | In distribution | |
| 82425035 | 6 | In distribution | |
| 6321006 | 6 | In distribution | |
| 671108 | 6 | In distribution | |
| 7325160 | 6 | In distribution | |
| 82421060 | 6 | In distribution | |
| 86421040 | 6 | In distribution | |
| 6853525 | 6 | In distribution | |
| 671109 | 6 | In distribution | |
| 6840625 | 6 | In distribution | |
| 668732 | In distribution | ||
| 6866021 | 6 | In distribution | |
| 87325045 | 6 | In distribution | |
| 86325035 | 6 | In distribution | |
| 671142 | 6 | In distribution | |
| 85325040 | 6 | In distribution | |
| 7331008 | 6 | In distribution | |
| 6866025 | 6 | In distribution | |
| 6843021 | 6 | In distribution | |
| 82321165 | 6 | In distribution | |
| 86331015 | 6 | In distribution | |
| 671112 | 6 | In distribution | |
| 82421030 | 6 | In distribution | |
| 6319160 | 6 | In distribution | |
| 82331060 | 6 | In distribution | |
| 82431160 | 6 | In distribution | |
| 671169 | 6 | In distribution | |
| 6844521 | 6 | In distribution | |
| 6331015 | 6 | In distribution | |
| 7321165 | 6 | In distribution | |
| 6325090 | 6 | In distribution | |
| 671167 | 6 | In distribution | |
| 86331080 | 6 | In distribution | |
| 82425025 | 6 | In distribution | |
| 671143 | 6 | In distribution | |
| 87321060 | 6 | In distribution | |
| 82825010 | 6 | In distribution | |
| 6858025 | 6 | In distribution | |
| 82325045 | 6 | In distribution | |
| 7331160 | 6 | In distribution | |
| 86321070 | 6 | In distribution | |
| 6842031 | 6 | In distribution | |
| 86331008 | 6 | In distribution | |
| 87331160 | 6 | In distribution | |
| 6841521 | 6 | In distribution | |
| 6845531 | 6 | In distribution | |
| 82431015 | 6 | In distribution | |
| 87331165 | 6 | In distribution | |
| 86421015 | 6 | In distribution | |
| 6860028 | 6 | In distribution | |
| 6331006 | 6 | In distribution | |
| 6325015 | 6 | In distribution | |
| 7331035 | 6 | In distribution | |
| 6525012 | 6 | In distribution | |
| 6844027 | 6 | In distribution | |
| 82325050 | 6 | In distribution | |
| 6844021 | 6 | In distribution | |
| 6331165 | 6 | In distribution | |
| 6321080 | 6 | In distribution | |
| 7321025 | 6 | In distribution | |
| 6845521 | 6 | In distribution | |
| 6844531 | 6 | In distribution | |
| 6864025 | 6 | In distribution | |
| 6701525 | 6 | In distribution | |
| 87331060 | 6 | In distribution | |
| 6847021 | 6 | In distribution | |
| 6331030 | 6 | In distribution | |
| 6862521 | 6 | In distribution | |
| 82421015 | 6 | In distribution | |
| 86331070 | 6 | In distribution | |
| 6842025 | 6 | In distribution | |
| 6842531 | 6 | In distribution | |
| 6325170 | 6 | In distribution | |
| 86325045 | 6 | In distribution | |
| 86331060 | 6 | In distribution | |
| 668733 | In distribution | ||
| 671102 | 6 | In distribution | |
| 6855024 | 6 | In distribution | |
| 6854021 | 6 | In distribution | |
| 6525015 | 6 | In distribution | |
| 82325015 | 6 | In distribution | |
| 7321160 | 6 | In distribution | |
| 86331010 | 6 | In distribution | |
| 6862031 | 6 | In distribution | |
| 82325030 | 6 | In distribution | |
| 82325070 | 6 | In distribution | |
| 82421045 | 6 | In distribution | |
| 7325050 | 6 | In distribution | |
| 86331045 | 6 | In distribution | |
| 6321020 | 6 | In distribution | |
| 6321008 | 6 | In distribution | |
| 6862021 | 6 | In distribution | |
| 6841021 | 6 | In distribution | |
| 82821015 | 6 | In distribution | |
| 6858021 | 6 | In distribution | |
| 6328008 | 6 | In distribution | |
| 6853521 | 6 | In distribution | |
| 7321010 | 6 | In distribution | |
| 82421025 | 6 | In distribution | |
| 6331008 | 6 | In distribution | |
| 87325015 | 6 | In distribution | |
| 82321160 | 6 | In distribution | |
| 86325165 | 6 | In distribution | |
| 86425025 | 6 | In distribution | |
| 6325175 | 6 | In distribution | |
| 6321017 | 6 | In distribution | |
| 671150 | 6 | In distribution | |
| 6521010 | 6 | In distribution | |
| 6331040 | 6 | In distribution | |
| 2632560 | 6 | In distribution | |
| 82321008 | 6 | In distribution | |
| 6851525 | 6 | In distribution | |
| 7325008 | 6 | In distribution | |
| 6865525 | 6 | In distribution | |
| 6328020 | 6 | In distribution | |
| 668722 | In distribution | ||
| 82425040 | 6 | In distribution | |
| 26325025 | 6 | In distribution | |
| 82825006 | 6 | In distribution | |
| 6325017 | 6 | In distribution | |
| 86321165 | 6 | In distribution | |
| 6321015 | 6 | In distribution | |
| 6857025 | 6 | In distribution | |
| 82325006 | 6 | In distribution | |
| 6845031 | 6 | In distribution | |
| 668708 | In distribution | ||
| 6321040 | 6 | In distribution | |
| 6861031 | 6 | In distribution | |
| 26325160 | 6 | In distribution | |
| 7331030 | 6 | In distribution | |
| 86331020 | 6 | In distribution | |
| 87325050 | 6 | In distribution | |
| 6840831 | 6 | In distribution | |
| 87325008 | 6 | In distribution | |
| 82331020 | 6 | In distribution | |
| 6844023 | 6 | In distribution | |
| 7325055 | 6 | In distribution | |
| 6421160 | 6 | In distribution | |
| 2632525 | 6 | In distribution | |
| 671139 | 6 | In distribution | |
| 86325010 | 6 | In distribution | |
| 7325170 | 6 | In distribution | |
| 6851531 | 6 | In distribution | |
| 87325010 | 6 | In distribution | |
| 86331035 | 6 | In distribution | |
| 7325035 | 6 | In distribution | |
| 7321015 | 6 | In distribution | |
| 7325010 | 6 | In distribution | |
| 6325040 | 6 | In distribution | |
| 6325165 | 6 | In distribution | |
| 7331015 | 6 | In distribution | |
| 671172 | 6 | In distribution | |
| 6841025 | 6 | In distribution | |
| 87331045 | 6 | In distribution | |
| 671113 | 6 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 720 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 658 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 526 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 456 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 283 |
| Avalon Biomed | Shenzhen Denco Medical Co., Ltd. | 233 |
| KP | Guilin Kevin Peter Technology Co., Ltd. | 216 |
| Dctaper | SS White Burs LLC | 205 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 205 |
| Edge File | US Endodontics, LLC | 202 |
| Komet Root Canal Files | Gebr. Brasseler Gmbh & Co. KG | 199 |
| K-Files | Diadent Group Intl., Inc. | 188 |
Showing 12 of 1,536. All products under File, Pulp Canal, Endodontic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K933582 | 1993-10-20 |
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.