Integra® Miltex®
Integra® Miltex® Dental Dam clamp, Style W8A
4manufacturers in China registered for this device type
36catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (2), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
Record
| Listed by | Integra LifeSciences Production Corporation, United States |
|---|---|
| FDA product code | EEF |
| Device type | Clamp, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-01-22 |
| Record revised | 2024-03-06 (version 7) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 76D-1A | In distribution | |
| 76D-W8A | In distribution | |
| 76D-24 | In distribution | |
| 76D-27N | In distribution | |
| 76D-1 | In distribution | |
| 76D-8A | In distribution | |
| 76D-14A | In distribution | |
| 76D-28 | In distribution | |
| 76D-18 | In distribution | |
| 76D-2A | In distribution | |
| 76D-W3 | In distribution | |
| 76D-5 | In distribution | |
| 76D-9 | In distribution | |
| 76D-30 | In distribution | |
| 76D-3 | In distribution | |
| 76D-7A | In distribution | |
| 76D-56 | In distribution | |
| 76D-29 | In distribution | |
| 76D-00 | In distribution | |
| 76D-12A | In distribution | |
| 76D-25 | In distribution | |
| 76D-26N | In distribution | |
| 76D-10 | In distribution | |
| 76D-7 | In distribution | |
| 76D-2 | In distribution | |
| 76D-4 | In distribution | |
| 76D-14 | In distribution | |
| 76D-0 | In distribution | |
| 76D-212 | In distribution | |
| 76D-205 | In distribution | |
| 76D-201 | In distribution | |
| 76D-26 | In distribution | |
| 76D-8 | In distribution | |
| 76D-11 | In distribution | |
| 76D-13A | In distribution | |
| 76D-27 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dentech | Dentech Corp. | 262 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 127 |
| Hygenic | Coltene/Whaledent Gmbh & Co. KG | 109 |
| Hysolate | DENT4YOU AG | 59 |
| Power Dental U.S.A., Inc. | Power Dental U.S.A. Inc. | 51 |
| Benco | Benco Dental Supply Co. | 41 |
| Power Dental USA | Power Dental U.S.A. Inc. | 18 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 15 |
| Osung MND | Osung MND Co., Ltd. | 13 |
| Burkhart Dental Supply | Burkhart Dental Supply Co., THE | 11 |
| Nivo | B. ALI Impex | 7 |
| Rubber Dam Clamps | HU-Friedy MFG Co., LLC | 6 |
Showing 12 of 114. All products under Clamp, 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.