FibreKleer 4x
Fiber Post Shape Tapered; 5x 1.25 mm, 1.375 mm, 1.50 mm Posts; 1x 1.25 mm, 1.375 mm, 1.50 mm Drills
10manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (2), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Shanghai Alwings Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 39 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Shenzhen Forever Medical Devices Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Kerr Corporation, United States |
|---|---|
| FDA product code | ELR |
| Device type | Post, Root Canal |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3810 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-08-01 |
| Record revised | 2021-12-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 25 °C |
| Sizes | Outer diameter 1 to 1.5 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N83CB | Outer Diameter 1.25 mm | 10 | In distribution |
| N83CA | Outer Diameter 1 mm | 10 | In distribution |
| N83CD | Outer Diameter 1 mm | 30 | In distribution |
| N83AD | Outer Diameter 1 mm | 30 | In distribution |
| N83CT | Outer Diameter 1.25 mm | 6 | In distribution |
| N83CC | Outer Diameter 1.5 mm | 10 | In distribution |
| N83AE | Outer Diameter 1.25 mm | 30 | In distribution |
| N83A | 5x 1.00 mm, 5x 1.25 mm, and and 5x 1.50 mm Fiber Posts; 1x 1.00 mm, 1x 1.25 mm, and 1x 1.50 mm | 18 | In distribution |
| N83CF | Outer Diameter 1.5 mm | 30 | In distribution |
| N83BC | Outer Diameter 1.5 mm | 10 | In distribution |
| N83AB | Outer Diameter 1.25 mm | 10 | In distribution |
| N83AF | Outer Diameter 1.5 mm | 30 | In distribution |
| N83BE | Outer Diameter 1.375 mm | 30 | In distribution |
| N83AC | Outer Diameter 1.5 mm | 10 | In distribution |
| N83C | 5x 1.00 mm, 5x 1.25 mm, and 5x 1.50 mm Fiber Posts; 1x 1.00 mm, 1x 1.25 mm, and 1x 1.50 mm Drill | 18 | In distribution |
| N83BB | Outer Diameter 1.375 mm | 10 | In distribution |
| N83B | 5x 1.25 mm, 5x 1.375 mm, 5x 1.50 mm Fiber Posts; 1x 1.25 mm, 1x 1.375 mm, 1x 1.50 mm Drills | 18 | In distribution |
| N83BD | Outer Diameter 1.25 mm | 30 | In distribution |
| N83AA | Outer Diameter 1 mm | 10 | In distribution |
| N83BT | Outer Diameter 1.25 mm | 6 | In distribution |
| N83CE | Outer Diameter 1.25 mm | 30 | In distribution |
| N83BA | Outer Diameter 1.25 mm | 10 | In distribution |
| N83AT | Outer Diameter 1.25 mm | 6 | In distribution |
| N83BF | Outer Diameter 1.5 mm | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 115 |
| ParaPost XP | Coltene/Whaledent Gmbh & Co. KG | 111 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 90 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 89 |
| Surtex | Dentatus AB | 84 |
| ParaPost | Coltene/Whaledent Gmbh & Co. KG | 46 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 44 |
| Two Striper | Abrasive Technology, LLC | 43 |
| Johnson-Promident | Young Innovations Inc. | 41 |
| Flexi-Post | Essential Dental Systems, Inc. | 40 |
| Biolight | Synca Marketing | 37 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 37 |
Showing 12 of 231. All products under Post, Root Canal
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.