PDT, Inc.
R256 - The PDT micro-serrated Periotome assists in making anterior extractions easier for the dentist and less traumatic for the patient.
2manufacturers in China registered for this device type
14catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EMO |
| Device type | Knife, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-27 |
| Record revised | 2025-08-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Over the counter | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T120 Luxating Instrument (2mm) | In distribution | |
| R444 End Cutting Intrasulcular Knife | In distribution | |
| R258 Periotome – Serrated de Posterior | In distribution | |
| R306 Gold Knife 7 | In distribution | |
| T122 Luxating Instrument (4mm) | In distribution | |
| R449 19-20 USC Towner Knife | In distribution | |
| R256 Periotome – Serrated de Anterior | In distribution | |
| R448 Kirkland 15-16 Knife | In distribution | |
| T123 Luxating Instrument (45mm) | In distribution | |
| T450 – Gingivectomy knife KIRKLAND, TRINOVO handle | In distribution | |
| R446 13-13KL Surgical Chisel | In distribution | |
| R305 14L Knife | In distribution | |
| R445 Modified Orban Knife | In distribution | |
| T121 Luxating Instrument (3mm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 36 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 35 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 35 |
| Zoll Dental | Zoll-Dental | 25 |
| Stoma® | Storz AM Mark Gmbh | 25 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 18 |
| Osung MND | Osung MND Co., Ltd. | 15 |
| Laschal Surgical | Laschal Surgical Instruments, LLC | 13 |
| Knife | KLS-Martin L.P. | 8 |
| American Eagle Instruments | American Eagle Instruments | 8 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 7 |
| Otto Leibinger | American Eagle Instruments | 7 |
Showing 12 of 114. All products under Knife, 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.