Integra® Miltex®
Integra® Miltex® DenLite® Disposable Mirrors, REF#'s DP1000, DP1500, 3 Boxes-72 each, 216 per Case
94manufacturers in China registered for this device type
86catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (23), Shanghai (15), Jiangsu (14). 9 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 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| 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 |
| Dongguan Shun King Company Limited | Dongguan | Guangdong | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Showing 12 of 94. All 94 manufacturers in China registered for Mirror, Mouth
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EAX |
| Device type | Mirror, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-16 |
| Record revised | 2023-04-27 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
| Distribution end date | 2022-05-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| DP1030-3 | 216 | In distribution | |
| 67-676/4 | 12 | In distribution | |
| 017-26806 | In distribution | ||
| 67-668/4 | 12 | In distribution | |
| 017-26808 | In distribution | ||
| 017-24803 | In distribution | ||
| 017-26807 | In distribution | ||
| 67-668/3 | 12 | In distribution | |
| 017-24800 | In distribution | ||
| 67-676/5 | 12 | In distribution | |
| 67-668/5 | 12 | In distribution | |
| 017-24801 | In distribution | ||
| 017-26805 | In distribution | ||
| 017-24802 | In distribution | ||
| 49001016 | 12 | Withdrawn | |
| 011-24694 | 12 | Withdrawn | |
| 011-24515 | Withdrawn | ||
| 49001010 | 12 | Withdrawn | |
| 011-24509 | Withdrawn | ||
| 011-24703 | Withdrawn | ||
| 011-24511 | Withdrawn | ||
| 011-24701 | Withdrawn | ||
| 011-24700 | Withdrawn | ||
| 67-672/4 | 12 | Withdrawn | |
| 49001011 | 12 | Withdrawn | |
| 011-24504 | Withdrawn | ||
| DP5400 | Withdrawn | ||
| 67724 | 6 | Withdrawn | |
| 49001008 | 12 | Withdrawn | |
| 011-24673 | Withdrawn | ||
| 67-664/3 | 12 | Withdrawn | |
| 011-24674 | 12 | Withdrawn | |
| 187-665-5 | 12 | Withdrawn | |
| 011-24510 | Withdrawn | ||
| 67-672/3 | 12 | Withdrawn | |
| 67-696/3 | 12 | Withdrawn | |
| 67725 | 6 | Withdrawn | |
| 49001014 | 12 | Withdrawn | |
| 011-24678 | 12 | Withdrawn | |
| 011-24692 | 12 | Withdrawn | |
| 67-698/4 | 12 | Withdrawn | |
| 011-24695 | 12 | Withdrawn | |
| 49001019 | 12 | Withdrawn | |
| 011-24677 | 12 | Withdrawn | |
| 49001017 | 12 | Withdrawn | |
| 67722 | 6 | Withdrawn | |
| 49001015 | 12 | Withdrawn | |
| D5 | 12 | Withdrawn | |
| 011-24507 | Withdrawn | ||
| 67-664/4 | 12 | Withdrawn | |
| 011-24503 | Withdrawn | ||
| 67-672/5 | 12 | Withdrawn | |
| 49001001 | 12 | Withdrawn | |
| 011-24514 | Withdrawn | ||
| 67-696/4 | 12 | Withdrawn | |
| 67723 | 6 | Withdrawn | |
| 011-24502 | Withdrawn | ||
| 49001013 | 12 | Withdrawn | |
| 011-24693 | 12 | Withdrawn | |
| DP5250 | Withdrawn | ||
| 011-24683 | Withdrawn | ||
| 49001023 | 12 | Withdrawn | |
| 187-665-4 | 12 | Withdrawn | |
| 011-24508 | Withdrawn | ||
| 011-24500 | Withdrawn | ||
| 49001024 | 12 | Withdrawn | |
| 49001003 | 12 | Withdrawn | |
| 49001018 | 12 | Withdrawn | |
| 011-24702 | Withdrawn | ||
| 49001021 | 12 | Withdrawn | |
| 49001009 | 12 | Withdrawn | |
| DP5150 | Withdrawn | ||
| 49001006 | 12 | Withdrawn | |
| 011-24680 | 12 | Withdrawn | |
| 67-698/3 | 12 | Withdrawn | |
| 67-664/5 | 12 | Withdrawn | |
| 011-24506 | Withdrawn | ||
| 67-698/5 | 12 | Withdrawn | |
| 011-24505 | Withdrawn | ||
| 49001020 | 12 | Withdrawn | |
| 011-24684 | Withdrawn | ||
| 67-696/5 | 12 | Withdrawn | |
| 49001007 | 12 | Withdrawn | |
| 011-24679 | 12 | Withdrawn | |
| 49001022 | 12 | Withdrawn | |
| 49001002 | 12 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| E. Hahnenkratt GmbH | E. Hahnenkratt Gmbh | 118 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 108 |
| Crystal HD® Mouth Mirrors | Zirc Dental Products, Inc. | 65 |
| Sklar® | Sklar Corporation | 60 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 59 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 43 |
| Osung MND | Osung MND Co., Ltd. | 39 |
| Mouth Mirror Handle | Zirc Dental Products, Inc. | 33 |
| Jedmed | Jedmed Instrument Company | 31 |
| Plasdent | Plasdent Corp. | 30 |
| Henry Schein | Henry Schein, Inc. | 27 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
Showing 12 of 205. All products under Mirror, Mouth
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.