Hu-Friedy MFG Co., LLC.
#3 explorer tip on a PH6 handle
8manufacturers in China registered for this device type
4catalogue numbers in this listing
7recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
| Shumei Industrial (Hebei) Co., Ltd. | Cangzhou | Hebei | Contract manufacturer | 10 |
| Guang Zhou Medclear Medical Device Service Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | EKB |
| Device type | Explorer, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-27 |
| Record revised | 2024-10-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Distribution end date | 2024-04-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XP7156 | In distribution | |
| EXD3ES7C | In distribution | |
| EXDJF176 | In distribution | |
| EPD7008 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 207 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 86 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 42 |
| Sklar® | Sklar Corporation | 39 |
| Premier Explorers | Premier Dental Products Co. | 35 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 32 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 28 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
Showing 12 of 77. All products under Explorer, Operative
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2005-01-07 | Not classified | Other | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification sette | 42,517 total units distributed (all date codes) | 2012-05-24 |
| 2005-01-07 | Not classified | Other | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification sette | 42,517 total units distributed (all date codes) | 2012-05-24 |
| 2005-01-07 | Not classified | Other | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification sette | 42,517 total units distributed (all date codes) | 2012-05-24 |
| 2005-01-07 | Not classified | Other | Potential for tip breakage at the terminal shank due to improper heat-treatment at the foreign plant. Several reports of tip breakage were received by the own label distributor, and forwarded to the importer of record & specification sette | 42,517 total units distributed (all date codes) | 2012-05-24 |
| 2004-03-29 | Not classified | Other | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the ins | 2012-08-02 | |
| 2004-03-29 | Not classified | Other | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the ins | 2012-08-02 | |
| 2004-03-29 | Not classified | Other | Reports of breakage on some dental explorers were received by the own label distributor and forwarded to Hu-Friedy Mfg. Co. (importer of record & Spec. Setter). Investigation conducted by Hu-Friedy Mfg. Co. revealed that the tips of the ins | 2012-08-02 |
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.