Integra® Miltex®
Integra® Miltex® College Cotton Pliers 317A, Extra Fine, Serrated
5manufacturers in China registered for this device type
13catalogue 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 | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EJY |
| Device type | Pliers, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-24 |
| Record revised | 2023-04-27 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66-317 | In distribution | |
| 66-317S | In distribution | |
| 66-312A | In distribution | |
| 66-656 | In distribution | |
| 66-311 | In distribution | |
| 66-318-49 | In distribution | |
| V966-317 | In distribution | |
| 66-318 | In distribution | |
| 66-317B | In distribution | |
| 66-49 | In distribution | |
| 66-652 | In distribution | |
| 66-317A | In distribution | |
| V966-652 | In distribution |
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 |
| 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 |
| Pliers | KLS-Martin L.P. | 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.