Integra® Miltex®
Integra® Miltex® Rubber Dam Frame Holder
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Hebei (2), Jiangsu (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Premium Plus (Dongguan) Limited | Dongguan | Guangdong | Repacker / relabeller | 34 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
| Shenzhen Yimi Care Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 15 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EJE |
| Device type | Frame, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-24 |
| Record revised | 2025-03-12 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7625 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nic Tone, MDC Dental | MDC Dental | 21 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 11 |
| Young | Young Dental Manufacturing I, LLC | 5 |
| Hysolate | DENT4YOU AG | 5 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 4 |
| Plast Frame | Hager Worldwide, Inc. | 3 |
| Dentech | Dentech Corp. | 2 |
| Benco | Benco Dental Supply Co. | 2 |
| Osung MND | Osung MND Co., Ltd. | 2 |
| Reicodent | Devemed Gmbh | 2 |
| Child Rubber Dam Frame – 13 cm | Berman Instruments LLC | 1 |
| TBS Basics | Acme Enterprise. | 1 |
Showing 12 of 16. All products under Frame, Rubber Dam
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.