Nordent Manufacturing Inc
Periotome Posterior, DE, Titanium-Nitride Coated, Posterior #2
5manufacturers in China registered for this device type
66catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Funing Meitedental Factory | Yancheng | Jiangsu | Manufacturer | 11 |
Record
| Listed by | Nordent Manufacturing Inc |
|---|---|
| FDA product code | EMR |
| Device type | File, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-07-08 |
| Record revised | 2021-01-22 (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 |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, 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 |
|---|---|---|
| FPH5-11T | In distribution | |
| FPH3-7T | In distribution | |
| REDF3 | In distribution | |
| CEDF2 | In distribution | |
| FPS1-2Y | In distribution | |
| FB21 | In distribution | |
| CEFPO12-13 | In distribution | |
| MALM1 | In distribution | |
| FPO12-13NCC | In distribution | |
| FB21X | In distribution | |
| EEPH5-11 | In distribution | |
| FPH5-11 | In distribution | |
| FPH9-10 | In distribution | |
| REFPS1-2 | In distribution | |
| CEFPS1-2 | In distribution | |
| CBM18 | In distribution | |
| FPBU17-18 | In distribution | |
| EFPH3-7 | In distribution | |
| REFPO12-13 | In distribution | |
| CEFB52 | In distribution | |
| FPO10-11NCC | In distribution | |
| CEDF1 | In distribution | |
| CBC9 | In distribution | |
| HOWMET3 | In distribution | |
| FPO12-13 | In distribution | |
| REDF1 | In distribution | |
| REFPO10-11 | In distribution | |
| CEDF3 | In distribution | |
| CEFPH9-10 | In distribution | |
| FB64 | In distribution | |
| CBG1 | In distribution | |
| FPS3-4 | In distribution | |
| FPO12-13Y | In distribution | |
| CEFPO10-11 | In distribution | |
| CEFPS3-4 | In distribution | |
| CEFPH5-11 | In distribution | |
| FPO10-11 | In distribution | |
| REFPS9-10 | In distribution | |
| FPS1-2 | In distribution | |
| CEEPTOME1 | Length 6.5 in | In distribution |
| REFPH9-10 | In distribution | |
| CEEPTOME1 | Length 6.5 in | In distribution |
| FPS9-10 | In distribution | |
| EFPO12-13 | In distribution | |
| FP* | In distribution | |
| EFPO10-11 | In distribution | |
| CBG5 | In distribution | |
| CBC8 | In distribution | |
| CEFB21 | In distribution | |
| FPBU13-14 | In distribution | |
| REDF2 | In distribution | |
| EFPH5-11 | In distribution | |
| REFPH3-7 | In distribution | |
| EFPS3-4 | In distribution | |
| REFPH5-11 | In distribution | |
| REFPS3-4 | In distribution | |
| *FP | In distribution | |
| EFPS1-2 | In distribution | |
| CEFPS9-10 | In distribution | |
| FB52 | In distribution | |
| FPO10-11Y | In distribution | |
| CEFPH3-7 | In distribution | |
| FPH3-7 | In distribution | |
| FPS3-4Y | In distribution | |
| CBG2 | In distribution | |
| FB12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kohdent | Kohler Medizintechnik GmbH | 48 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 26 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 21 |
| Quinelato | Schobell Industrial Ltda | 16 |
| Power Dental USA | Power Dental U.S.A. Inc. | 10 |
| Zoll-Dental | Zoll-Dental | 10 |
| Sterling | Benco Dental Supply Co. | 9 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 8 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 8 |
| devemed | Devemed Gmbh | 6 |
| Reicodent | Devemed Gmbh | 6 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 4 |
Showing 12 of 39. All products under File, Periodontic
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.