A. Titan Instruments
Ultradent Bone File, Large Handle, Gold Coated Tips
5manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Funing Meitedental Factory | Yancheng | Jiangsu | Manufacturer | 11 |
Record
| Listed by | A. Titan Instruments, Inc., United States |
|---|---|
| FDA product code | EMR |
| Device type | File, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ULTRA BF003 | In distribution | |
| ULTRA BF004 | In distribution | |
| ULTRA BF002 | In distribution | |
| ULTRA BF001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 66 |
| Kohdent | Kohler Medizintechnik GmbH | 48 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 26 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 21 |
| Quinelato | Schobell Industrial Ltda | 16 |
| Power Dental USA | Power Dental U.S.A. Inc. | 10 |
| Zoll-Dental | Zoll-Dental | 10 |
| Sterling | Benco Dental Supply Co. | 9 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 8 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 8 |
| devemed | Devemed Gmbh | 6 |
| Reicodent | Devemed Gmbh | 6 |
Showing 12 of 39. All products under File, Periodontic
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.