Brasseler USA
76D-13A Rubber DAM Clamp 1P
4manufacturers in China registered for this device type
15catalogue 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 | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EEF |
| Device type | Clamp, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
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 |
|---|---|---|
| 5014497U0 | In distribution | |
| 5014491U0 | In distribution | |
| 5014500U0 | In distribution | |
| 5014490U0 | In distribution | |
| 5014496U0 | In distribution | |
| 5014492U0 | In distribution | |
| 5014502U0 | In distribution | |
| 5012017U0 | In distribution | |
| 5025246U0 | In distribution | |
| 5014493U0 | In distribution | |
| 5014494U0 | In distribution | |
| 5014498U0 | In distribution | |
| 5014499U0 | In distribution | |
| 5014501U0 | In distribution | |
| 5014495U0 | 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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 36 |
| Power Dental USA | Power Dental U.S.A. Inc. | 18 |
| 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.