Mini 1 Flexible-Thin Composite Instrument
Catalogue number CFTM01, listed by Berman Instruments LLC, under Burnisher, Operative. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Shandong (1). 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Berman Instruments LLC |
|---|---|
| FDA product code | EKJ |
| Device type | Burnisher, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-09-21 |
| Record revised | 2024-11-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CFTM01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 157 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 58 |
| Power Dental USA | Power Dental U.S.A. Inc. | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 24 |
| J & J Instruments Inc | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 21 |
| Zoll-Dental | Zoll-Dental | 16 |
| PDT, Inc. | PDT, Inc. | 14 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 14 |
| Henry Schein | Henry Schein, Inc. | 7 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 5 |
Showing 12 of 54. All products under Burnisher, Operative
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.