Carver, Wax, Dental
A dental instrument used to carve wax patterns, which can be heated for softening the wax while fashioning the pattern.
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Guangdong (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 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
Record
| Listed by | YDM Corporation, Japan |
|---|---|
| FDA product code | EIK |
| Device type | Carver, Wax, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 07160 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 120 |
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 34 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 22 |
| J & J Instruments | J & J Instruments, LLC | 21 |
| Pomee | Pomee Corporation | 16 |
| Henry Schein | Henry Schein, Inc. | 16 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 13 |
| TBS Basics | Acme Enterprise. | 12 |
| Osung MND | Osung MND Co., Ltd. | 12 |
| Buffalo Dental Mfg | Buffalo Dental Manufacturing Co., Inc. | 9 |
| Zoll-Dental | Zoll-Dental | 9 |
| Premier Lab Instruments | Premier Dental Products Co. | 5 |
Showing 12 of 51. All products under Carver, Wax, Dental
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.