PDT, Inc.
PA-Files Sugarmann TRINOVO handle
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Funing Meitedental Factory | Yancheng | Jiangsu | Manufacturer | 11 |
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EMR |
| Device type | File, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-22 |
| Record revised | 2025-08-05 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T455 – PA-Files Sugarmann TRINOVO Handle | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 66 |
| Kohdent | Kohler Medizintechnik GmbH | 48 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 26 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 21 |
| Quinelato | Schobell Industrial Ltda | 16 |
| Power Dental USA | Power Dental U.S.A. Inc. | 10 |
| Zoll-Dental | Zoll-Dental | 10 |
| Sterling | Benco Dental Supply Co. | 9 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 8 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 8 |
| devemed | Devemed Gmbh | 6 |
| Reicodent | Devemed Gmbh | 6 |
Showing 12 of 39. All products under File, Periodontic
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.