Prima
8 catalogue numbers from 15070K, listed by Keystone Dental Inc., United States, under Chisel (Osteotome). 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Keystone Dental Inc., United States |
|---|---|
| FDA product code | KDG |
| Device type | Chisel (Osteotome) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4820 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K051614 |
| Record published | 2019-05-08 |
| Record revised | 2025-12-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15070K | In distribution | |
| 15068K | In distribution | |
| 15074K | In distribution | |
| 15071K | In distribution | |
| 15073K | In distribution | |
| 15069K | In distribution | |
| 15072K | In distribution | |
| 15067K | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 531 |
| Quinelato | Schobell Industrial Ltda | 70 |
| Novo Surgical | Novo Surgical, Inc. | 67 |
| Stille Osteotomes | Stille AB | 65 |
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 65 |
| Orthomed | Ortho-MED, Inc. | 58 |
| Life Instruments | Life Instrument Corp. | 57 |
| Princeton | Princeton Medical Group, Inc. | 46 |
| Osteotome | Koros U.S.A., Inc. | 41 |
| Elmed | Elmed, Inc. | 41 |
| Anmuth Medical International | Anmuth Medical International LLC | 32 |
| Aesculap | Aesculap AG | 31 |
Showing 12 of 55. All products under Chisel (Osteotome)
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.