2 catalogue numbers from 11-240, listed by Hankil Tech Medical Co., Ltd., South Korea, under Chisel, Osteotome, Surgical. 4 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Bent Osteotome | Listed by | Hankil Tech Medical Co., Ltd., South Korea |
| FDA product code | EMM |
| Device type | Chisel, Osteotome, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2026-07-15 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Label carries | lot or batch number, manufacturing date |
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.