Pliers
Wire, Obwegeser, Flat, W/Groove
5manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zhejiang Risheng Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 8 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| ISA Mould Engineering Limted | Dongguan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | KLS-Martin L.P., United States |
|---|---|
| FDA product code | EJY |
| Device type | Pliers, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-26 |
| Record revised | 2021-04-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-04-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47-697-15-07 | 15.5 CM | In distribution |
| 48-192-01-07 | 12.5 CM | In distribution |
| 48-192-02-07 | 14.5 CM | In distribution |
| 38-684-41-07 | 15.5 CM | In distribution |
| 48-194-13-07 | 13 CM | In distribution |
| 47-788-13-07 | 13 CM | Withdrawn |
| 47-751-14-07 | 14 CM | Withdrawn |
| 47-750-14-07 | 14 CM | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 49 |
| Henry Schein | Henry Schein, Inc. | 22 |
| PDT, Inc. | PDT, Inc. | 14 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 12 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 10 |
| J&J Instruments | J & J Instruments, LLC | 10 |
| Kohdent | Kohler Medizintechnik GmbH | 9 |
| Pomee | Pomee Corporation | 8 |
| Leone SPA | Leone SPA | 7 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 7 |
| Aesthetic Aligner | Zatty Industria Comercio Importacao E Exportacao DE Instrumentacao Cirurgica E Odontologica Ltda | 7 |
Showing 12 of 102. All products under Pliers, Operative
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.