FDA Registration
Active
🇺🇸 United States
430 SWL RA Handpieces - 266182, 266183
Reg #: 2520265
·
FEI: 2520265
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DENTALEZ, INC., STARDENTAL DIVISION
- Registration Number
- 2520265
- FEI Number
- 2520265
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1816 Colonial Village Ln
- City
- Lancaster
- State
- PA
- ZIP
- 17601
- Country
- US
Regulatory Submissions
- 510(k) Number
- K896361
Owner / Operator
- Firm Name
- DENTALEZ, INC.
- Operator Number
- 2513147
- Address
- 301 Lindenwood Drive, Suite 100
- City
- Malvern
- State
- PA
- Postal Code
- 19355
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Handpiece, Air-Powered, Dental | EFB | Class 1 | Dental | No | 2007-10-10 |
Proprietary Names
430 SWL RA Handpieces - 266182, 266183
430 Series High-Speed Handpieces - 268840, 264450, 268841, 262057, 262052, 264451, 268861, 264951, 264952
430 SWL Flex Handpieces - 266153, 266154
Establishment Types
Manufacture Medical Device