Hysolate
HySolate Fiesta Dental Dam Clamp Set winged #2, #2A, #4, #7, #8A, #9, #12A, #13A, #14A , 9 clamps
4manufacturers in China registered for this device type
59catalogue 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 | DENT4YOU AG, Switzerland |
|---|---|
| FDA product code | EEF |
| Device type | Clamp, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-02-28 |
| Record revised | 2024-12-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-12-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H02706 | In distribution | ||
| H02763 | In distribution | ||
| H09957 | In distribution | ||
| H01052 | In distribution | ||
| H01051 | In distribution | ||
| H02800 | In distribution | ||
| H02770 | In distribution | ||
| H02794 | In distribution | ||
| H02759 | In distribution | ||
| H02704 | In distribution | ||
| H09964 | In distribution | ||
| H03814 | In distribution | ||
| H02701 | 9 | In distribution | |
| H02766 | In distribution | ||
| H02801 | 9 | In distribution | |
| H02778 | 7 | In distribution | |
| H02900 | 9 | In distribution | |
| H09965 | In distribution | ||
| H05690 | In distribution | ||
| H02769 | In distribution | ||
| H07792 | In distribution | ||
| H01048 | In distribution | ||
| H02764 | In distribution | ||
| H02757 | In distribution | ||
| H09960 | In distribution | ||
| H02762 | In distribution | ||
| H02767 | In distribution | ||
| 60019066 | 9 | In distribution | |
| H05689 | In distribution | ||
| H01049 | In distribution | ||
| H02703 | In distribution | ||
| H02797 | In distribution | ||
| H02761 | In distribution | ||
| H02795 | In distribution | ||
| H09959 | In distribution | ||
| H02799 | In distribution | ||
| H09958 | In distribution | ||
| H09962 | In distribution | ||
| H02790 | 7 | In distribution | |
| H02796 | In distribution | ||
| H01053 | In distribution | ||
| H01054 | 6 | In distribution | |
| H03815 | In distribution | ||
| H02774 | In distribution | ||
| H02802 | In distribution | ||
| H02775 | In distribution | ||
| H05688 | In distribution | ||
| H02803 | In distribution | ||
| H09966 | 9 | In distribution | |
| H09961 | In distribution | ||
| H02760 | In distribution | ||
| H02705 | In distribution | ||
| H02758 | In distribution | ||
| H09963 | In distribution | ||
| H02798 | In distribution | ||
| H02765 | In distribution | ||
| H01050 | In distribution | ||
| H02768 | In distribution | ||
| H09956 | 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 |
| 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 |
| 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.