Sklar®
Cleoid Discoid Carver DE #wacd
5manufacturers in China registered for this device type
33catalogue 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 | Sklar Corporation, United States |
|---|---|
| FDA product code | EKH |
| Device type | Carver, Dental Amalgam, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-11 |
| Record revised | 2020-09-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 49-1315 | In distribution | |
| 49-1260 | In distribution | |
| 49-1272 | In distribution | |
| 49-1295 | In distribution | |
| 49-1273 | In distribution | |
| 49-1210 | In distribution | |
| 49-1235 | In distribution | |
| 49-1205 | In distribution | |
| 49-1305 | In distribution | |
| 49-1220 | In distribution | |
| 49-1310 | In distribution | |
| 49-1271 | In distribution | |
| 48-424 | In distribution | |
| 48-428 | In distribution | |
| 49-1230 | In distribution | |
| 49-1325 | In distribution | |
| 48-296 | In distribution | |
| 49-1280 | In distribution | |
| 48-288 | In distribution | |
| 49-3105 | In distribution | |
| 48-422 | In distribution | |
| 49-1290 | In distribution | |
| 49-1215 | In distribution | |
| 49-1200 | In distribution | |
| 49-1285 | In distribution | |
| 49-1225 | In distribution | |
| 48-228 | In distribution | |
| 49-1320 | In distribution | |
| 49-1255 | In distribution | |
| 49-1270 | In distribution | |
| 49-1250 | In distribution | |
| 49-1300 | In distribution | |
| 49-3110 | In distribution |
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 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 29 |
| Reicodent | Devemed Gmbh | 29 |
| Premier Carvers | Premier Dental Products Co. | 20 |
| J & J Instruments Inc | J & J Instruments, LLC | 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.