Integra® Miltex®
Integra® Miltex® Cord Packer, Retraction, Double-Ended, Serrated Tips
5manufacturers in China registered for this device type
58catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), Shandong (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 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EKJ |
| Device type | Burnisher, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-19 |
| Record revised | 2024-04-05 (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 | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 71-28 | In distribution | |
| 71-22 | In distribution | |
| 71-24 | In distribution | |
| 71-26 | In distribution | |
| 71-20 | In distribution | |
| 71-30 | In distribution | |
| 71-40 | In distribution | |
| TB230 | Withdrawn | |
| TNBL2 | Withdrawn | |
| TBFP2A | Withdrawn | |
| TBPKT3 | Withdrawn | |
| TB2729KA | Withdrawn | |
| TBPFI21 | Withdrawn | |
| TB2729-KK | Withdrawn | |
| TB2 | Withdrawn | |
| TNPACSI1 | Withdrawn | |
| TNBL1 | Withdrawn | |
| TNPA1 | Withdrawn | |
| TBPKT3P | Withdrawn | |
| TB226 | Withdrawn | |
| TB2526 | Withdrawn | |
| TB21B | Withdrawn | |
| TB115 | Withdrawn | |
| TB21C | Withdrawn | |
| TB2628 | Withdrawn | |
| TB21-GW | Withdrawn | |
| TB1LA | Withdrawn | |
| TB21B-KK | Withdrawn | |
| TB18P | Withdrawn | |
| RB229 | Withdrawn | |
| TB234 | Withdrawn | |
| TB2629 | Withdrawn | |
| TNPKT1-GG | Withdrawn | |
| TBLA3 | Withdrawn | |
| UB32 | Withdrawn | |
| TB19P | Withdrawn | |
| TNPKT1-KK | Withdrawn | |
| UB34 | Withdrawn | |
| TB230X-GR | Withdrawn | |
| TB2730-KG | Withdrawn | |
| TBLA3-GW | Withdrawn | |
| TB2729WD | Withdrawn | |
| TB2630 | Withdrawn | |
| TNPA2 | Withdrawn | |
| TB21 | Withdrawn | |
| TB2729-KA | Withdrawn | |
| TB2729 | Withdrawn | |
| TB2627 | Withdrawn | |
| 80-6202 | Withdrawn | |
| TB2829 | Withdrawn | |
| RB2729 | Withdrawn | |
| TNPKT1 | Withdrawn | |
| TB21-GR | Withdrawn | |
| TBNYUB1 | Withdrawn | |
| TBPKT3-KK | Withdrawn | |
| TB18P-GR | Withdrawn | |
| 80-6204 | Withdrawn | |
| 80-6201 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 157 |
| Power Dental USA | Power Dental U.S.A. Inc. | 28 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 24 |
| J & J Instruments Inc | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 21 |
| Zoll-Dental | Zoll-Dental | 16 |
| PDT, Inc. | PDT, Inc. | 14 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 14 |
| Henry Schein | Henry Schein, Inc. | 7 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 5 |
| Burkhart Dental | Nordent Manufacturing Inc | 5 |
Showing 12 of 54. All products under Burnisher, 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.