Aesculap
Round Condenser/Spatula F.microendodont.
2manufacturers in China registered for this device type
21catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | EKG |
| Device type | Condenser, Amalgam And Foil, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-06-17 |
| Record revised | 2023-08-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2025-07-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DE059R | In distribution | |
| DE050R | In distribution | |
| DE051R | In distribution | |
| DF263R | In distribution | |
| DE055R | In distribution | |
| DE054R | In distribution | |
| DE052R | In distribution | |
| DE444R | In distribution | |
| DE053R | In distribution | |
| DE445R | In distribution | |
| DF088R | In distribution | |
| DE440R | In distribution | |
| DE060R | In distribution | |
| DE442R | In distribution | |
| DE443R | In distribution | |
| DE058R | In distribution | |
| DE057R | In distribution | |
| DE056R | Withdrawn | |
| DF261R | Withdrawn | |
| DF260R | Withdrawn | |
| DF262R | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 199 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 107 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 50 |
| Pomee | Pomee Corporation | 44 |
| Zoll-Dental | Zoll-Dental | 17 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 12 |
| Kohdent | Kohler Medizintechnik GmbH | 12 |
| Ergoplant | Aesculap AG | 10 |
| Quinelato | Schobell Industrial Ltda | 9 |
| Osung MND | Osung MND Co., Ltd. | 9 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 9 |
| PDT, Inc. | PDT, Inc. | 6 |
Showing 12 of 51. All products under Condenser, Amalgam And Foil, Operative
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.