Rematitan®
rematitan® attachment, 90 °, complete Ti-plastic female part
4manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Hebei (1), Hunan (1). 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 |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | Cangzhou | Hebei | Manufacturer | 40 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Record
| Listed by | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | EBL |
| Device type | Pin, Retentive And Splinting, And Accessory Instruments |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3740 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-15 |
| Record revised | 2018-11-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
| Distribution end date | 2021-06-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 240-035-00 | Withdrawn | |
| 240-015-00 | Withdrawn | |
| 210-020-00 | Withdrawn | |
| 210-021-00 | Withdrawn | |
| 240-025-00 | Withdrawn | |
| 210-012-00 | Withdrawn | |
| 240-036-00 | Withdrawn | |
| 210-010-00 | Withdrawn | |
| 240-020-00 | Withdrawn | |
| 240-012-00 | Withdrawn | |
| 240-010-00 | Withdrawn | |
| 240-037-00 | Withdrawn | |
| 240-031-00 | Withdrawn | |
| 210-022-00 | Withdrawn | |
| 240-022-00 | Withdrawn | |
| 210-011-00 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Blue Sky Bio, LLC | Blue SKY BIO, LLC | 571 |
| Edenta | Edenta Etablissement | 155 |
| TMS | Coltene/Whaledent Gmbh & Co. KG | 46 |
| Code Rings | Pulpdent Corporation | 31 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 19 |
| Stabilok | Fairfax Medical Products Ltd | 8 |
| Pin, Retentive And Splinting, And Accessory Instruments | Dentaurum GmbH & Co. KG | 6 |
| Bondent | Coltene/Whaledent Gmbh & Co. KG | 6 |
| Core Forms | Pulpdent Corporation | 5 |
| SRH3427LBlue Sky Bio, LLC | Blue SKY BIO, LLC | 5 |
| Max | Coltene/Whaledent Gmbh & Co. KG | 4 |
| Biotem | Biotem Co., Ltd. | 3 |
Showing 12 of 62. All products under Pin, Retentive And Splinting, And Accessory Instruments
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.