Integra® Miltex®
Tactile-Tone™ Endodontic Spreaders, Set of 5, Nickel Titanium, Single-Ended
19manufacturers in China registered for this device type
69catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 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 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
Showing 12 of 19. All 19 manufacturers in China registered for Plugger, Root Canal, Endodontic
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKR |
| Device type | Plugger, Root Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2023-04-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 71-35 | In distribution | ||
| UF35 | Withdrawn | ||
| TF911BLB | Withdrawn | ||
| UF120X | Withdrawn | ||
| UF80N | Withdrawn | ||
| UF70 | Withdrawn | ||
| TFD6080NXL | Withdrawn | ||
| 017-24633 | Withdrawn | ||
| TF57 | Withdrawn | ||
| TFD100140X | Withdrawn | ||
| UF100X | Withdrawn | ||
| 017-24622 | Withdrawn | ||
| 012-23012 | 6 | Withdrawn | |
| TFD6080N | Withdrawn | ||
| 017-24603 | Withdrawn | ||
| UF35N | Withdrawn | ||
| 017-24490 | Withdrawn | ||
| UF45N | Withdrawn | ||
| TFD3545NXL | Withdrawn | ||
| TF4070N4 | Withdrawn | ||
| TF57BL | Withdrawn | ||
| 017-24632 | Withdrawn | ||
| UF60N | Withdrawn | ||
| UF55 | Withdrawn | ||
| UF30 | Withdrawn | ||
| 017-24623 | Withdrawn | ||
| 012-23005 | 6 | Withdrawn | |
| 017-24601 | Withdrawn | ||
| 012-23010 | 6 | Withdrawn | |
| 012-23015 | 6 | Withdrawn | |
| UF60 | Withdrawn | ||
| 017-24631 | Withdrawn | ||
| 012-23002 | 6 | Withdrawn | |
| 012-23011 | 6 | Withdrawn | |
| UF80 | Withdrawn | ||
| XER | Withdrawn | ||
| TF57BLB | Withdrawn | ||
| 012-23001 | 6 | Withdrawn | |
| 017-24500 | Withdrawn | ||
| 017-24590 | Withdrawn | ||
| UF30N | Withdrawn | ||
| UF50 | Withdrawn | ||
| 012-23007 | Withdrawn | ||
| 017-24602 | Withdrawn | ||
| UF25N | Withdrawn | ||
| TF911 | Withdrawn | ||
| UF45NT | Withdrawn | ||
| 012-23014 | 6 | Withdrawn | |
| 017-24621 | Withdrawn | ||
| UF25 | Withdrawn | ||
| TF911BL | Withdrawn | ||
| 017-24600 | Withdrawn | ||
| TF13 | Withdrawn | ||
| UF60NT | Withdrawn | ||
| TF911-KB | Withdrawn | ||
| TF57-KB | Withdrawn | ||
| 012-23004 | 6 | Withdrawn | |
| UF45 | Withdrawn | ||
| 012-23016 | Withdrawn | ||
| 017-24620 | Withdrawn | ||
| 017-24630 | Withdrawn | ||
| UF40N | Withdrawn | ||
| 017-24510 | Withdrawn | ||
| 012-23003 | 6 | Withdrawn | |
| 012-23006 | 6 | Withdrawn | |
| TFTE6X | Withdrawn | ||
| UF140X | Withdrawn | ||
| UF80NT | Withdrawn | ||
| TFD3545N | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 268 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 93 |
| Power Dental USA | Power Dental U.S.A. Inc. | 82 |
| Needle | B&L Biotech Co., Inc. | 40 |
| American Eagle Instruments | American Eagle Instruments | 33 |
| Henry Schein | Henry Schein, Inc. | 33 |
| Premier Pluggers | Premier Dental Products Co. | 29 |
| EQ-V | Meta Systems Co., Ltd. | 26 |
| Obtura Spartan | Young Innovations Inc. | 25 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 22 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 22 |
| Edge Endo | Handpiece Parts & Repairs, Inc. | 21 |
Showing 12 of 136. All products under Plugger, Root Canal, Endodontic
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.