A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a…
A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.
Who Else Makes It
Registered in Shandong.
Record
Regulatory record for Osung MND | Listed by | Osung MND Co., Ltd., South Korea |
| FDA product code | EKA |
| Device type | File, Margin Finishing, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-27 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
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.