Dentech
2 catalogue numbers from 01022010, listed by Dentech Corp., Japan, under Frame, Rubber Dam. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Dentech Corp., Japan |
|---|---|
| FDA product code | EJE |
| Device type | Frame, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01022010 | In distribution | |
| 01022020 | 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 |
| 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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 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.