Hygenic
Fiesta 9 Wingless Color Coded Clamp Pack
4manufacturers in China registered for this device type
109catalogue 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 | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EEF |
| Device type | Clamp, Rubber Dam |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-01 |
| Record revised | 2020-01-09 (version 2) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H02798C | In distribution | ||
| H09960C | In distribution | ||
| H01049 | In distribution | ||
| H09962C | In distribution | ||
| H02703C | In distribution | ||
| H09963C | In distribution | ||
| H02796C | In distribution | ||
| H09957 | In distribution | ||
| H02765 | In distribution | ||
| H01054C | In distribution | ||
| H02799 | In distribution | ||
| H02763C | In distribution | ||
| H02764C | In distribution | ||
| H02759C | In distribution | ||
| H05690C | In distribution | ||
| H01048C | In distribution | ||
| H05690 | In distribution | ||
| H01053C | In distribution | ||
| H02774 | In distribution | ||
| H01050C | In distribution | ||
| H02803C | In distribution | ||
| H02761C | In distribution | ||
| H05688 | In distribution | ||
| H07792 | In distribution | ||
| H09958 | In distribution | ||
| H02763 | In distribution | ||
| H02767C | In distribution | ||
| H02766 | In distribution | ||
| H02766C | In distribution | ||
| H02706C | In distribution | ||
| H01053 | In distribution | ||
| H02802C | In distribution | ||
| H02760C | In distribution | ||
| H09956 | In distribution | ||
| H01049C | In distribution | ||
| H03815 | In distribution | ||
| H02801C | In distribution | ||
| H09963 | In distribution | ||
| H02798 | In distribution | ||
| H02706 | In distribution | ||
| H09966C | In distribution | ||
| H05689C | In distribution | ||
| H09957C | In distribution | ||
| H09959C | In distribution | ||
| H02768 | In distribution | ||
| H02762C | In distribution | ||
| H02794C | In distribution | ||
| H01052 | In distribution | ||
| H02769 | In distribution | ||
| H02759 | In distribution | ||
| H09965 | In distribution | ||
| H02757C | In distribution | ||
| H02774C | In distribution | ||
| H09962 | In distribution | ||
| H02758C | In distribution | ||
| H02795 | In distribution | ||
| H02701 | 9 | In distribution | |
| H02757 | In distribution | ||
| H02704C | In distribution | ||
| H03815C | In distribution | ||
| H09964 | In distribution | ||
| H02767 | In distribution | ||
| H02800C | In distribution | ||
| H02794 | In distribution | ||
| H02801 | 9 | In distribution | |
| H01050 | In distribution | ||
| H02760 | In distribution | ||
| H02705C | In distribution | ||
| H05689 | In distribution | ||
| H02775 | In distribution | ||
| H09961C | In distribution | ||
| H05688C | In distribution | ||
| H09965C | In distribution | ||
| H02765C | In distribution | ||
| H01054 | 6 | In distribution | |
| H02701C | In distribution | ||
| H01052C | In distribution | ||
| H02803 | In distribution | ||
| H02704 | In distribution | ||
| H02761 | In distribution | ||
| H03814 | In distribution | ||
| H02770C | In distribution | ||
| H09959 | In distribution | ||
| H02768C | In distribution | ||
| H03814C | In distribution | ||
| H01048 | In distribution | ||
| H02703 | In distribution | ||
| H02705 | In distribution | ||
| H02758 | In distribution | ||
| H02799C | In distribution | ||
| H02775C | In distribution | ||
| H01051 | In distribution | ||
| H07792C | In distribution | ||
| H09960 | In distribution | ||
| H09961 | In distribution | ||
| H02797C | In distribution | ||
| H02797 | In distribution | ||
| H09958C | In distribution | ||
| H02762 | In distribution | ||
| H09964C | In distribution | ||
| H09966 | 12 | In distribution | |
| H02800 | In distribution | ||
| H01051C | In distribution | ||
| H02796 | In distribution | ||
| H02802 | In distribution | ||
| H02764 | In distribution | ||
| H02795C | In distribution | ||
| H02769C | In distribution | ||
| H02770 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dentech | Dentech Corp. | 262 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 127 |
| 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 |
| 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.