FDA Registration
Active
🇺🇸 United States
REF05 ClearCorrect System Aligner (Single Layer)
Reg #: 3007130440
·
FEI: 3007130440
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- ClearCorrect , LLC
- Registration Number
- 3007130440
- FEI Number
- 3007130440
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 21 Cypress Blvd Ste 1010
- City
- Round Rock
- State
- TX
- ZIP
- 78665
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113618
Owner / Operator
- Firm Name
- INSTITUT STRAUMANN AG
- Operator Number
- 9005052
- Address
- PETER MERIAN-WEG 12
- City
- BASEL
- State
- CH-NOTA
- Postal Code
- CH-4002
- Country
- CH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Aligner, Sequential | NXC | Class 2 | Dental | No | 2020-06-11 |
Proprietary Names
REF05 ClearCorrect System Aligner (Single Layer)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device