Press Form Sheets
Press Form Sheets, SOFT,.080
4manufacturers in China registered for this device type
3catalogue 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 | Cynosure, LLC, United States |
|---|---|
| FDA product code | EBL |
| Device type | Pin, Retentive And Splinting, And Accessory Instruments |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3740 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-21 |
| Record revised | 2023-01-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| EPS352 | 15 | In distribution | |
| EPS351 | 15 | In distribution | |
| EPS1776 | 15 | 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 |
| 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 |
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.