Waterpik Densco Condensaire Condenser Tip
Medium round tip
2manufacturers in China registered for this device type
4catalogue 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 | Water PIK, Inc., 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 | 2020-08-31 |
| Record revised | 2025-09-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Distribution end date | 2025-09-15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000809-000 | Withdrawn | |
| 000810-000 | Withdrawn | |
| 000812-000 | Withdrawn | |
| 000811-000 | Withdrawn |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 |
| 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.