FDA Registration
Active
🇨🇳 China
AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct
Reg #: 3004046477
·
FEI: 3004046477
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Suzhou Pac-Dent Technology Co., Ltd
- Registration Number
- 3004046477
- FEI Number
- 3004046477
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18 Yuanqi Road
- City
- SUZHOU CITY Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K030603
Owner / Operator
- Firm Name
- Pac-Dent Inc.
- Operator Number
- 10056434
- Address
- 670 Endeavor Cir
- City
- Brea
- State
- CA
- Postal Code
- 92821
- Country
- US
- Correspondent
- Tom Peng
US Agent
- Business Name
- PAC-DENT, INC.
- Contact Name
- Tom Peng
- Address
- 670 Endeavor Cir
- City
- Brea
- State
- CA
- ZIP
- 92821
- Country
- US
- [email protected]
- Phone
- 909 8390888
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2017-12-11 |
Proprietary Names
AntiSplatr Flex Slim Disposable Prophy Angle, 90 Degree, Flex Cup, 200ct
Freestyle Pro
ProMate
ProAngle
ProMate EZ-Q Quick Disconnect Hygiene Handpiece
AntiSplatr Disposable Prophy Angles
ProMateEZ-Q Quick Disconnect Coupler
ProMate EZ-Q Quick Disconnect Combo- Hygiene Handpiece and Coupler
ACCLEAN ERGO PROPHY ANGLE LF
AntiSplatr Flex Slim disposable Prophy Angle Bulk Pack, 90 Degree, Flex Cup, 1,200ct
AntiSplatr Flex Ergo Slim Disposable Prophy Angle, Contra Angle, Flex Cup, 200ct
AntiSplatr Flex Ergo Slim Disposable Prophy Angle Bulk Pack, Contra Angle, Flex Cup, 1,200ct
Establishment Types
Manufacture Medical Device