Hygenic
Dental DAM Forceps
7manufacturers in China registered for this device type
3catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Rude Medical Apparatus AND Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
Record
| Listed by | Coltene/Whaledent Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | EJG |
| Device type | Forceps, Rubber Dam Clamp |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6300 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-03-05 |
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 | Status |
|---|---|---|
| H01262C | In distribution | |
| H01262 | In distribution | |
| H01261 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TBS Basics | Acme Enterprise. | 17 |
| Aesculap | Aesculap AG | 9 |
| Composi-Tight® | Garrison Dental Solutions, L.L.C. | 7 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 7 |
| BL Clamp | B&L Biotech Co., Inc. | 6 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 5 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 5 |
| Zoll-Dental | Zoll-Dental | 5 |
| Quinelato | Schobell Industrial Ltda | 4 |
| Stoma® | Storz AM Mark Gmbh | 3 |
| Bioclear Instrument | Bioclear Matrix Systems, LLC | 3 |
| Advance Dental Products | THE Atlanta Dental Supply Company | 3 |
Showing 12 of 28. All products under Forceps, Rubber Dam Clamp
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2020-06-03 | Class II | Process control | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | 7,206 forceps |
| 2020-06-03 | Class II | Process control | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | 7,206 forceps |
| 2020-06-03 | Class II | Process control | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | 7,206 forceps |
| 2020-06-03 | Class II | Process control | Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps. | 7,206 forceps |
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.