Millennium
Mandibular Awl, Slightly curved
5manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Guangxi (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 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | EML |
| Device type | Chisel, Bone, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-22 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 17-010072 | In distribution | |
| 17-090400 | In distribution | |
| 85-780P91227 | In distribution | |
| 17-016210 | In distribution | |
| 17-017830 | In distribution | |
| 17-010442 | In distribution | |
| 17-010458 | In distribution | |
| 85-78091277 | In distribution | |
| 85-78092112 | In distribution | |
| 17-090399 | In distribution | |
| 17-010441 | In distribution | |
| 17-010073 | In distribution | |
| 17-017825 | In distribution | |
| 17-010443 | In distribution | |
| 17-010075 | In distribution | |
| 85-78091257 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 71 |
| Quinelato | Schobell Industrial Ltda | 55 |
| Stoma® | Storz AM Mark Gmbh | 33 |
| devemed | Devemed Gmbh | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| Power Dental USA | Power Dental U.S.A. Inc. | 24 |
| J & J Instruments | J & J Instruments, LLC | 17 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 16 |
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 14 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 14 |
| Pilling | Teleflex Medical LLC | 12 |
Showing 12 of 50. All products under Chisel, Bone, Surgical
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.