TMS
MINIKIN Single Shear Complete Kit - Titanium
4manufacturers in China registered for this device type
46catalogue 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 | 2019-02-11 |
| 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 |
|---|---|---|---|
| T108 | 50 | In distribution | |
| L551 | 23 | In distribution | |
| L741 | 22 | In distribution | |
| L841 | 23 | In distribution | |
| L751 | 23 | In distribution | |
| L511 | 22 | In distribution | |
| T112 | 50 | In distribution | |
| L731 | 23 | In distribution | |
| L541 | 22 | In distribution | |
| T13 | 22 | In distribution | |
| T06 | 100 | In distribution | |
| L742 | 50 | In distribution | |
| T01 | 100 | In distribution | |
| L502 | 50 | In distribution | |
| T15 | 100 | In distribution | |
| L542 | 50 | In distribution | |
| L821 | 22 | In distribution | |
| T01 | 22 | In distribution | |
| T04 | 22 | In distribution | |
| T09 | 102 | In distribution | |
| T10 | 22 | In distribution | |
| L722 | 50 | In distribution | |
| T05 | 50 | In distribution | |
| T08 | 50 | In distribution | |
| T107 | 22 | In distribution | |
| T111 | 22 | In distribution | |
| T02 | 50 | In distribution | |
| L521 | 22 | In distribution | |
| L752 | 50 | In distribution | |
| L732 | 50 | In distribution | |
| L531 | 23 | In distribution | |
| L512 | 50 | In distribution | |
| T12 | 100 | In distribution | |
| T11 | 50 | In distribution | |
| T03 | 100 | In distribution | |
| L811 | 22 | In distribution | |
| L552 | 50 | In distribution | |
| T14 | 50 | In distribution | |
| L822 | 50 | In distribution | |
| T07 | 22 | In distribution | |
| L501 | 22 | In distribution | |
| L812 | 50 | In distribution | |
| L532 | 50 | In distribution | |
| L522 | 50 | In distribution | |
| L842 | 50 | In distribution | |
| L721 | 22 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Blue Sky Bio, LLC | Blue SKY BIO, LLC | 571 |
| Edenta | Edenta Etablissement | 155 |
| 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 |
| 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
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.