Endodontic Posts
DISPOSABLE Titanium device with tilting head to be cemented into the root canal, with retentive pink caps, metal housing for the caps, directional rings and protective disc.
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 | Rhein 83 SRL, Italy |
|---|---|
| FDA product code | ELR |
| Device type | Post, Root Canal |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3810 |
| Establishment | Contract manufacturer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-12 |
| Record revised | 2021-01-28 (version 2) |
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, manufacturing date |
| Distribution end date | 2021-01-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PIVOT tit. EQUATOR mm.10 | In distribution | |
| TITANIUM PIVOT KIT MICRO size mm.10 pz.5 | In distribution | |
| PIVOT tit. EQUATOR mm.7 set | In distribution | |
| PIVOT FLEX mm.10,2 RIV.TiN | In distribution | |
| PIVOT FLEX mm.7.50 RIV.TiN | In distribution | |
| PIVOT tit. EQUATOR mm.9 set | In distribution | |
| PIVOT tit. EQUATOR mm.7 | In distribution | |
| PIVOT tit. EQUATOR mm.10 set | In distribution | |
| TITANIUM PIVOTS KIT STD./size mm.7 pz.5 | In distribution | |
| PIVOT FLEX mm.9 | In distribution | |
| PIVOT tit. EQUATOR mm.9 | In distribution | |
| TITANIUM PIVOTS KIT MICRO size mm.7 pz.5 | In distribution | |
| TITANIUM PIVOTS KIT MICRO size mm.9 pz.5 | In distribution | |
| TITANIUM PIVOTS KIT STD./size mm.10 pz.5 | In distribution | |
| TITANIUM PIVOTS KIT STD./size mm.9 pz.5 | Withdrawn | |
| PIVOT tit. EQUATOR mm.9 | Withdrawn | |
| TITANIUM PIVOTS KIT MICRO size mm.7 pz.5 | Withdrawn | |
| PIVOT tit. EQUATOR mm.7 set | Withdrawn | |
| TITANIUM PIVOTS KIT MICRO size mm.9 pz.5 | Withdrawn | |
| TITANIUM PIVOTS KIT STD./size mm.10 pz.5 | Withdrawn | |
| PIVOT tit. EQUATOR mm.9 set | Withdrawn | |
| PIVOT FLEX mm.9 | Withdrawn | |
| TITANIUM PIVOTS KIT STD./size mm.7 pz.5 | Withdrawn | |
| PIVOT tit. EQUATOR mm.7 | Withdrawn | |
| PIVOT FLEX mm.7,0 RIV.TiN | Withdrawn | |
| PIVOT tit. EQUATOR mm.10 | Withdrawn | |
| PIVOT FLEX mm.10,2 RIV.TiN | Withdrawn | |
| TITANIUM PIVOT KIT MICRO size mm.10 pz.5 | Withdrawn | |
| PIVOT FLEX mm.7,0 RIV.TiN | Withdrawn | |
| PIVOT FLEX mm.7.50 RIV.TiN | Withdrawn | |
| PIVOT tit. EQUATOR mm.10 set | Withdrawn |
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.