FDA Registration
Active
🇨🇳 China
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD
Reg #: 3017618678
·
FEI: 3017618678
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO., LTD
- Registration Number
- 3017618678
- FEI Number
- 3017618678
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO.9 Changyang road, West Taihu Science Techology Industrial Park
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213947
Owner / Operator
- Firm Name
- ChangZhou BoMedent Medical Technology Co., Ltd
- Operator Number
- 10078266
- Address
- NO.9 Changyang road, West Taihu Science Techology Industrial Park
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213100
- Country
- CN
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Filling, Plastic, Dental | EIY | Class 1 | Dental | No | 2021-03-12 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 2023-10-26 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2022-09-12 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2021-03-12 |
| Locator, Root Apex | LQY | Class U | Unknown | No | 2020-10-16 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2020-10-16 |
Proprietary Names
Endodontic Obturation Devices
SCM-019, iBon, iBon Mini, iBon Mini-SE
Ultrasonic Endo Activation Device (Model: Actor I pro)
Dental Electrical Motor iRoot Pro
BOMEDENT Apex locator, WISMY Apex locator
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)