Integra® Miltex®
Integra® Miltex® Jaquette Scaler 6-3/4", Double-Ended, No. 2 and No. 3, Octagonal Handle
34manufacturers in China registered for this device type
77catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (15), Shandong (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| 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 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 34. All 34 manufacturers in China registered for Scaler, Periodontic
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EMN |
| Device type | Scaler, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-18 |
| Record revised | 2023-05-02 (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 |
| Distribution end date | 2023-12-04 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 70-114 | In distribution | |
| 70-118 | In distribution | |
| 70-126 | In distribution | |
| 70-100 | In distribution | |
| 70-104 | In distribution | |
| 70-112 | In distribution | |
| 70-108 | In distribution | |
| 70-120 | In distribution | |
| 70-122 | In distribution | |
| 70-102 | In distribution | |
| 70-110 | In distribution | |
| 70-116 | In distribution | |
| 70-164 | In distribution | |
| 70-124 | In distribution | |
| 70-794 | Withdrawn | |
| TP107108 | Withdrawn | |
| 80-5004 | Withdrawn | |
| 70-714 | Withdrawn | |
| TPTHJR | Withdrawn | |
| TPU67 | Withdrawn | |
| 70-5006 | Withdrawn | |
| TPNE128 | Withdrawn | |
| 70-722 | Withdrawn | |
| 80-5008 | Withdrawn | |
| TPJ1SU5 | Withdrawn | |
| 70-5003 | Withdrawn | |
| 80-5000 | Withdrawn | |
| TPBY12-DW | Withdrawn | |
| TPBY12 | Withdrawn | |
| TPH67 | Withdrawn | |
| TPJ33H5 | Withdrawn | |
| TP204SD | Withdrawn | |
| TP204S | Withdrawn | |
| 70-802 | Withdrawn | |
| 80-5007 | Withdrawn | |
| 70-720 | Withdrawn | |
| 70-94 | Withdrawn | |
| TPJ23 | Withdrawn | |
| 70-5001 | Withdrawn | |
| 80-5001 | Withdrawn | |
| 70-719 | Withdrawn | |
| 70-769 | Withdrawn | |
| 80-5002 | Withdrawn | |
| 70-5008 | Withdrawn | |
| TPH5U15 | Withdrawn | |
| TPJ30H5 | Withdrawn | |
| TPJ3033 | Withdrawn | |
| TPCK6 | Withdrawn | |
| 70-762 | Withdrawn | |
| 70-90 | Withdrawn | |
| 70-5005 | Withdrawn | |
| 70-5004 | Withdrawn | |
| 80-5005 | Withdrawn | |
| 70-731 | Withdrawn | |
| TPJ33U15 | Withdrawn | |
| UPNE128 | Withdrawn | |
| 70-760 | Withdrawn | |
| 80-5006 | Withdrawn | |
| 70-767 | Withdrawn | |
| 80-5003 | Withdrawn | |
| TPJ3132 | Withdrawn | |
| 70-5002 | Withdrawn | |
| TPJ2S3S | Withdrawn | |
| 70-721 | Withdrawn | |
| 70-5007 | Withdrawn | |
| 70-96 | Withdrawn | |
| TPJ3435 | Withdrawn | |
| 70-800 | Withdrawn | |
| 70-92 | Withdrawn | |
| 70-724 | Withdrawn | |
| TP204 | Withdrawn | |
| 70-768 | Withdrawn | |
| 70-5000 | Withdrawn | |
| TPBY12-UU | Withdrawn | |
| TPJ30U15 | Withdrawn | |
| 70-796 | Withdrawn | |
| TPJN | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 468 |
| American Eagle Instruments | American Eagle Instruments | 269 |
| Zoll-Dental | Zoll-Dental | 255 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 207 |
| Power Dental USA | Power Dental U.S.A. Inc. | 202 |
| Osung MND | Osung MND Co., Ltd. | 102 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 85 |
| Sklar® | Sklar Corporation | 81 |
| Henry Schein | Henry Schein, Inc. | 79 |
| PDT, Inc. | PDT, Inc. | 67 |
| House Brand Dentistry | Frontier Dental Supply Inc | 65 |
| J & J Instruments | J & J Instruments, LLC | 56 |
Showing 12 of 216. All products under Scaler, Periodontic
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.