Nordent Manufacturing Inc
Composite Placement, DE, Titanium-Nitride Coated, #21 Paddle/# 20 Condenser (2.0 mm), DuraLite ROUND Handle
2manufacturers in China registered for this device type
107catalogue 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 | Nordent Manufacturing Inc |
|---|---|
| FDA product code | EKG |
| Device type | Condenser, Amalgam And Foil, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-06-15 |
| Record revised | 2023-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Handling environment humidity 40 to 60 % RH; Handling environment temperature 0 to 350 °F; Storage environment temperature 65 to 75 °F |
| Sizes | Length 6.5 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CN1-S-8 | In distribution | |
| CECN4-P-8 | In distribution | |
| ECN6-P-8 | In distribution | |
| RCN1-P-4 | In distribution | |
| CN10-P-BR29 | In distribution | |
| CECNH1 | In distribution | |
| RECN6-S-8 | In distribution | |
| CNI-P-10 | In distribution | |
| RECN1-P-8 | In distribution | |
| RECN4-P-10 | In distribution | |
| CECN6S8 | In distribution | |
| CECNB6-7 | In distribution | |
| CN0-S-1 | In distribution | |
| RECSPLG1 | Length 6.5 in | In distribution |
| CECN0-P-1 | In distribution | |
| RCN10S-N120 | Length 6.5 in | In distribution |
| RCN0-S-1 | In distribution | |
| *CN | In distribution | |
| CECNH2 | In distribution | |
| CN0-P-1 | In distribution | |
| ECN1-P-4 | In distribution | |
| ECN4-P-10 | In distribution | |
| CN4-P-6 | In distribution | |
| CECN4-S-10 | In distribution | |
| RECN4-P-6 | Length 6.5 in | In distribution |
| ECN0-P-1 | In distribution | |
| RCN6-P-8 | In distribution | |
| RECNMORT | In distribution | |
| CECN0-P-1 | Length 6.5 in | In distribution |
| CECNMORT | In distribution | |
| ECN1-S-8 | In distribution | |
| CNB6-7 | In distribution | |
| CECN4-S-8 | In distribution | |
| CN1-P-4T | In distribution | |
| CN0-S-4 | In distribution | |
| CECN1-P-4 | In distribution | |
| RECN6-P-8 | In distribution | |
| RECN1-S-8 | In distribution | |
| RECN6-P-10 | In distribution | |
| CN6-S-8 | In distribution | |
| CNMORT2 | In distribution | |
| CECN0-S-1 | In distribution | |
| REPCOW-23 | In distribution | |
| RECN6-P-10 | Length 6.5 in | In distribution |
| CECN1S8 | In distribution | |
| CN1-P-4 | In distribution | |
| CN4-P-10 | In distribution | |
| CN0-P-4 | In distribution | |
| ECN1-P-8 | In distribution | |
| RECN4-S-10 | In distribution | |
| ECN0-S-1 | In distribution | |
| CN1-S-10 | In distribution | |
| RECN4-S-6 | In distribution | |
| RECNMORT2 | In distribution | |
| CNOR2 | In distribution | |
| CN8-P-10 | In distribution | |
| CECN6-P-8 | In distribution | |
| RECN4-P-6 | In distribution | |
| RECSPLG1 | Length 6.5 in | In distribution |
| RECN0-S-1 | Length 6.5 in | In distribution |
| RECN4-S-8 | In distribution | |
| RECNH2 | In distribution | |
| CNOR4 | In distribution | |
| BRYWESTCO | In distribution | |
| CECN1-P-4 | Length 6.5 in | In distribution |
| CN1-S-4 | In distribution | |
| CNOR3 | In distribution | |
| CECN1-P-8 | In distribution | |
| AMP0002H | In distribution | |
| RECNH1 | In distribution | |
| ECNMORT | In distribution | |
| CNB4-5 | In distribution | |
| CNH1 | In distribution | |
| RECN4-P-8 | In distribution | |
| CN4-P-8T | In distribution | |
| CN4-S-10 | In distribution | |
| REPFI21TA-20TB | Length 6.5 in | In distribution |
| CN4-S-8 | In distribution | |
| CN1-P-8 | In distribution | |
| CECN1-S-4 | In distribution | |
| RECN0-P-1T | In distribution | |
| RECN0-P-1 | In distribution | |
| RECN1-P-4 | In distribution | |
| RECN0-S-4 | In distribution | |
| CNH2 | In distribution | |
| CN4-S-6 | In distribution | |
| CNMORT | In distribution | |
| CNW3 | In distribution | |
| CN8-S-10 | In distribution | |
| RECN1-S-4 | In distribution | |
| CN6-P-10 | In distribution | |
| ECNB6-7 | In distribution | |
| CN* | In distribution | |
| CECN1P4 | In distribution | |
| PLUG1T | In distribution | |
| CECNMORT2 | In distribution | |
| RECN0-S-1 | In distribution | |
| CN6-P-8 | In distribution | |
| AMP0001H | In distribution | |
| *ECN | In distribution | |
| RECNB6-7 | In distribution | |
| CN4-P-8 | In distribution | |
| CN1-P-10 | In distribution | |
| CNS8-U15 | In distribution | |
| RECN4-S-6 | Length 6.5 in | In distribution |
| CECN4-P-10 | In distribution | |
| RCNH2 | Length 6.5 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 199 |
| 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 |
| 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.