FDA Registration
Active
🇺🇸 United States
Titan EX Angles
Reg #: 2520265
·
FEI: 2520265
·
Expires 2025
Products
1
Proprietary Names
16
Establishment Types
3
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
- K983574
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, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2007-10-10 |
Proprietary Names
Titan EX Angles
Titan-E 20K Motor
Titan EX Motor 20K
Titan EX Attachments
Star Titan 20K Motor FX
Star Titan 5K Motor FX
Titan 3 Motors
Star Titan 20K Motor SW
Star Titan 5K Motor SW
Titan-T Motors
Titan 3 Lubricated Angles
Titan 3 Attachments
Titan-T Lubefree Angles
Titan 3 Lubefree Angles
Titan-T Attachments
Titan-T Lubricated Angles
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device