AccessPost Overdenture
AccessPost Overdenture Accessories (Studs Size 1)
10manufacturers in China registered for this device type
13catalogue numbers in this listing
1510(k) clearance
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 | Essential Dental Systems, Inc., United States |
|---|---|
| FDA product code | ELR |
| Device type | Post, Root Canal |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3810 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-07-10 |
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, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 527-01 | In distribution | |
| 525-02 | In distribution | |
| 585-01 | In distribution | |
| 580-01 | In distribution | |
| 515-00 | In distribution | |
| 520-02 | In distribution | |
| 585-03 | In distribution | |
| 525-03 | In distribution | |
| 585-02 | In distribution | |
| 520-03 | In distribution | |
| 520-01 | In distribution | |
| 510-00 | In distribution | |
| 525-01 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K896693 | 1990-02-14 |
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.