Brasseler USA
Chyn WAX Carver Hylin #2 HDL 1P
4manufacturers in China registered for this device type
22catalogue numbers in this listing
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 | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EIK |
| Device type | Carver, Wax, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2023-08-10 (version 2) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5026161U0 | In distribution | |
| 5023724U0 | In distribution | |
| 5023725U0 | In distribution | |
| 5023723U0 | In distribution | |
| 5023715U0 | In distribution | |
| 5023709U0 | In distribution | |
| 5032029U0 | In distribution | |
| 5023708U0 | In distribution | |
| 5032031U0 | In distribution | |
| 5019152U0 | In distribution | |
| 5023713U0 | In distribution | |
| 5023727U0 | In distribution | |
| 5023721U0 | In distribution | |
| 5023726U0 | In distribution | |
| 5023707U0 | In distribution | |
| 5023722U0 | In distribution | |
| 5023728U0 | In distribution | |
| 5014554U0 | In distribution | |
| 5023712U0 | In distribution | |
| 5023718U0 | In distribution | |
| 5032030U0 | In distribution | |
| 5023714U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 120 |
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 34 |
| 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 |
| PDT, Inc. | PDT, Inc. | 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.