J & J Instruments Inc
Hollenback Carver #3S (1/2)
5manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
Record
| Listed by | J & J Instruments, LLC, United States |
|---|---|
| FDA product code | EKH |
| Device type | Carver, Dental Amalgam, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-10-18 |
| Record revised | 2023-06-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Sizes | Length 1.875 to 7 in |
| Distribution end date | 2018-10-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03-310 | In distribution | |
| 03-330 | In distribution | |
| 03-230 | Length 6.25 in | In distribution |
| 03-190 | Length 7 in | In distribution |
| 03-191 | Length 4 in | In distribution |
| 03-350 | Length 6.75 in | In distribution |
| 03-320 | Length 7 in | In distribution |
| 03-193 | Length 1.875 in | In distribution |
| 03-460 | Length 6.375 in | In distribution |
| 03-335 | Length 6.625 in | In distribution |
| 03-450 | Length 6.625 in | In distribution |
| 03-195 | Length 6.75 in | In distribution |
| 03-360 | Length 6.75 in | In distribution |
| 03-410 | Length 6.25 in | In distribution |
| 03-340 | Length 6.75 in | In distribution |
| 03-200 | Length 6.625 in | In distribution |
| 03-300 | Length 6.5 in | In distribution |
| 03-430 | Length 7 in | In distribution |
| 03-192 | Length 1.875 in | In distribution |
| 03-470 | Length 6.625 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 284 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 154 |
| American Eagle Instruments | American Eagle Instruments | 72 |
| Zoll-Dental | Zoll-Dental | 43 |
| Power Dental USA | Power Dental U.S.A. Inc. | 39 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 38 |
| Sklar® | Sklar Corporation | 33 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 29 |
| Reicodent | Devemed Gmbh | 29 |
| Premier Carvers | Premier Dental Products Co. | 20 |
| devemed | Devemed Gmbh | 16 |
| PDT, Inc. | PDT, Inc. | 16 |
Showing 12 of 41. All products under Carver, Dental Amalgam, Operative
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.