Bondent
Bondent Bulk Kit - Short Pins - Titanium
4manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
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 | Coltene/Whaledent 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-26 |
| Record revised | 2019-10-23 (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 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DB50ST | 50 | In distribution | |
| DB50LT | 50 | In distribution | |
| DB50L | 50 | In distribution | |
| DB20SL | 24 | In distribution | |
| DB20SLT | 24 | In distribution | |
| DB50S | 50 | In distribution |
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 |
| rematitan® | Dentaurum GmbH & Co. KG | 16 |
| Stabilok | Fairfax Medical Products Ltd | 8 |
| Pin, Retentive And Splinting, And Accessory Instruments | Dentaurum 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
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 |
|---|---|---|---|---|
| 2021-03-18 | Class II | Under Investigation by firm | The incorrect dental pins were packaged and subsequently distributed. | 65 packs of 20 pins |
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.