ParaPost
20 ParaPost Plastic Impression Posts - .045
10manufacturers in China registered for this device type
46catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | ELR |
| Device type | Post, Root Canal |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3810 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-11 |
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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P463 | 20 | In distribution | |
| P845 | 10 | In distribution | |
| P4445B | 25 | In distribution | |
| P846 | 10 | In distribution | |
| P445 | 10 | In distribution | |
| P446 | 10 | In distribution | |
| P4345 | 20 | In distribution | |
| P447B | 25 | In distribution | |
| PF1715C | 5 | In distribution | |
| P437 | 20 | In distribution | |
| P4445 | 10 | In distribution | |
| PF1713C | 5 | In distribution | |
| P844 | 10 | In distribution | |
| P8455 | 10 | In distribution | |
| P4455 | 10 | In distribution | |
| PF17155C | 5 | In distribution | |
| P464 | 20 | In distribution | |
| P4455B | 25 | In distribution | |
| P445B | 25 | In distribution | |
| P443B | 25 | In distribution | |
| P436 | 20 | In distribution | |
| P4645 | 20 | In distribution | |
| P434 | 20 | In distribution | |
| P467 | 20 | In distribution | |
| P444B | 25 | In distribution | |
| P843 | 10 | In distribution | |
| P4655 | 20 | In distribution | |
| P466 | 20 | In distribution | |
| P4355 | 20 | In distribution | |
| PF1816C | 5 | In distribution | |
| PF1815C | 5 | In distribution | |
| P465 | 20 | In distribution | |
| L596 | 2 | In distribution | |
| PF18155C | 5 | In distribution | |
| P447 | 10 | In distribution | |
| PF18145C | 5 | In distribution | |
| PF1714C | 5 | In distribution | |
| PF17145C | 5 | In distribution | |
| P446B | 25 | In distribution | |
| PF1716C | 5 | In distribution | |
| P444 | 10 | In distribution | |
| P433 | 20 | In distribution | |
| P847 | 10 | In distribution | |
| P435 | 20 | In distribution | |
| P443 | 10 | In distribution | |
| P8445 | 10 | 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 |
| 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 |
| Endodontic Posts | Rhein 83 SRL | 31 |
Showing 12 of 231. All products under Post, Root Canal
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K993545 | 2000-04-14 |
| K000311 | 2000-03-14 |
| K934192 | 1994-06-06 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-08-21 | Class II | Process control | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 | 30 packets | 2020-04-10 |
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.