Intrace USA
Amalgam Carrier, Double-Ended, Regular & Large Tips, Lever/Plunger Action, 200 mm (8") Length, Stainless Steel, Reusable.
2manufacturers in China registered for this device type
2catalogue 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 | Pilotis Tech LLC, United States |
|---|---|
| FDA product code | EKG |
| Device type | Condenser, Amalgam And Foil, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-03 |
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 |
| Sizes | Length 200 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ANE-07-394 | In distribution | |
| ANE-04-340 | Length 200 mm | In distribution |
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 |
| Aesculap | Aesculap AG | 21 |
| 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 |
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.