Power Dental U.S.A., Inc.
Rubber DAM Clamps KIT With 12 DAM PLATE..(0 1 2 2S 4 5 8A 12A 13A 9S 56 212)..
4manufacturers in China registered for this device type
51catalogue 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 | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | EEF |
| Device type | Clamp, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Premarket notification | Exempt |
| Record published | 2021-06-20 |
| Record revised | 2022-12-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Distribution end date | 2022-12-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N7220 | In distribution | |
| N7232 | In distribution | |
| N7221 | In distribution | |
| N7246N | In distribution | |
| N7218 | In distribution | |
| N7217 | In distribution | |
| N7248 | In distribution | |
| N7215 | In distribution | |
| N7247 | In distribution | |
| N7211 | In distribution | |
| N7216 | In distribution | |
| N7210 | In distribution | |
| N7209 | In distribution | |
| N7201 | In distribution | |
| N7222 | In distribution | |
| N7207 | In distribution | |
| N7235 | In distribution | |
| N7203 | In distribution | |
| N7233 | In distribution | |
| N7253 | In distribution | |
| N7224 | In distribution | |
| N7208 | In distribution | |
| N7219 | In distribution | |
| N7249 | In distribution | |
| N7251 | In distribution | |
| N7250 | In distribution | |
| N7230 | In distribution | |
| N7223 | In distribution | |
| N7255 | In distribution | |
| N7231 | In distribution | |
| N7257 | In distribution | |
| N7227 | In distribution | |
| N7228 | In distribution | |
| N7261 | In distribution | |
| N7213 | In distribution | |
| N7206 | In distribution | |
| N7252 | In distribution | |
| N7229 | In distribution | |
| N7234 | In distribution | |
| N7226 | In distribution | |
| N7204 | In distribution | |
| N7225 | In distribution | |
| N7212 | Withdrawn | |
| N7205 | Withdrawn | |
| N7260 | Withdrawn | |
| N7256 | Withdrawn | |
| N7259 | Withdrawn | |
| N7258 | Withdrawn | |
| N7254 | Withdrawn | |
| N7214 | Withdrawn | |
| N7202 | Withdrawn |
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 |
| Benco | Benco Dental Supply Co. | 41 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 36 |
| 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.