Integra® Miltex®
Reamers, Right Angle, #2, Spiral Taper - 3 Pack
10manufacturers in China registered for this device type
67catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Innovative Material & Devices, Inc. | Wuxi | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKP |
| Device type | Reamer, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-03 |
| Record revised | 2022-07-13 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DR21/15-40 | Withdrawn | ||
| 017-41202 | 3 | Withdrawn | |
| 012-12067 | 6 | Withdrawn | |
| DR25/30 | 6 | Withdrawn | |
| DR21/10 | 6 | Withdrawn | |
| 012-12061 | 6 | Withdrawn | |
| DR25/10 | 6 | Withdrawn | |
| 012-12009 | 6 | Withdrawn | |
| 012-12071 | 6 | Withdrawn | |
| 012-12013 | 6 | Withdrawn | |
| 012-12003 | 6 | Withdrawn | |
| DR25/20 | 6 | Withdrawn | |
| 012-12065 | 6 | Withdrawn | |
| 012-12074 | 6 | Withdrawn | |
| 012-12184 | 6 | Withdrawn | |
| 012-12195 | 6 | Withdrawn | |
| 012-12196 | Withdrawn | ||
| 012-12193 | 6 | Withdrawn | |
| 012-12194 | 6 | Withdrawn | |
| 012-12015 | 6 | Withdrawn | |
| DR21/08 | 6 | Withdrawn | |
| 012-12014 | 6 | Withdrawn | |
| 012-12183 | 6 | Withdrawn | |
| 012-12006 | 6 | Withdrawn | |
| DR25/25 | 6 | Withdrawn | |
| 012-12011 | 6 | Withdrawn | |
| DR21/30 | 6 | Withdrawn | |
| 012-12063 | 6 | Withdrawn | |
| 012-12189 | Withdrawn | ||
| 012-12186 | 6 | Withdrawn | |
| 012-12010 | Withdrawn | ||
| 012-12185 | 6 | Withdrawn | |
| 012-12004 | 6 | Withdrawn | |
| 012-12187 | 6 | Withdrawn | |
| 012-12005 | 6 | Withdrawn | |
| 012-12070 | 6 | Withdrawn | |
| DR21/25 | 6 | Withdrawn | |
| 012-12069 | Withdrawn | ||
| 012-12062 | 6 | Withdrawn | |
| 012-12066 | 6 | Withdrawn | |
| 012-12068 | 6 | Withdrawn | |
| 012-12017 | Withdrawn | ||
| DR25/15 | 6 | Withdrawn | |
| DR25/40 | 6 | Withdrawn | |
| 012-12075 | 6 | Withdrawn | |
| DR25/70 | 6 | Withdrawn | |
| 012-12064 | 6 | Withdrawn | |
| 012-12002 | 6 | Withdrawn | |
| 012-12181 | 6 | Withdrawn | |
| 012-12008 | 6 | Withdrawn | |
| 012-12073 | 6 | Withdrawn | |
| DR25/08 | 6 | Withdrawn | |
| 012-12072 | 6 | Withdrawn | |
| DR21/40 | 6 | Withdrawn | |
| DR21/20 | 6 | Withdrawn | |
| 012-12182 | 6 | Withdrawn | |
| 012-12192 | 6 | Withdrawn | |
| DR25/15-40 | Withdrawn | ||
| 012-12012 | 6 | Withdrawn | |
| 012-12007 | 6 | Withdrawn | |
| 012-12190 | 6 | Withdrawn | |
| DR21/45 | 6 | Withdrawn | |
| 012-12191 | 6 | Withdrawn | |
| 012-12076 | Withdrawn | ||
| DR21/15 | 6 | Withdrawn | |
| 012-12016 | 6 | Withdrawn | |
| 012-12188 | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 133 |
| Mani Reamers | Mani, Inc. | 106 |
| K-Reamers | Tulsa Dental Products LLC | 103 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 82 |
| K-Reamers | Micro-Mega SA | 72 |
| M-access® K-Reamer | Maillefer Instruments Holding Sàrl | 69 |
| Mani Engine Reamers | Mani, Inc. | 64 |
| Optimum | Benco Dental Supply Co. | 60 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 60 |
| Endodontic Hand Instruments | Tulsa Dental Products LLC | 49 |
| SafeSiders | Essential Dental Systems, Inc. | 40 |
| Endodontic Hand Instruments | Roydent Dental Products, Inc. | 28 |
Showing 12 of 195. All products under Reamer, Pulp 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.