FDA Registration
Active
🇺🇸 United States
gel etch
Reg #: 1000118628
·
FEI: 1000118628
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC.
- Registration Number
- 1000118628
- FEI Number
- 1000118628
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 2928 Metro Street, Suite 102
- City
- Denton
- State
- TX
- ZIP
- 76207
- Country
- US
Regulatory Submissions
- 510(k) Number
- K875313
Owner / Operator
- Firm Name
- Five Star Orthodontic Laboratory & Supply, Inc.
- Operator Number
- 10033551
- Address
- 2928 Metro Street, Suite 102
- City
- Denton
- State
- TX
- Postal Code
- 76207
- Country
- US
- Correspondent
- John J Loch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2016-09-23 |
Proprietary Names
gel etch
Establishment Types
Repack or Relabel Medical Device