FDA Registration
Active
🇺🇸 United States
ALLURE ORTHO
Reg #: 3012771684
·
FEI: 3012771684
·
Expires 2026
Products
9
Proprietary Names
1
Establishment Types
2
Classifications
9
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Registration Details
- Registration Name
- ALLURE ORTHO
- Registration Number
- 3012771684
- FEI Number
- 3012771684
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1 Main St, #10
- City
- Whitinsville
- State
- MA
- ZIP
- 01588
- Country
- US
Regulatory Submissions
- 510(k) Number
- K221194
Owner / Operator
- Firm Name
- ALLURE ORTHO
- Operator Number
- 10052651
- Address
- 1 Main St, # 10
- City
- Whitinsville
- State
- MA
- Postal Code
- 01588
- Country
- US
- Correspondent
- Jody M Fitzsimmons
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2016-09-01 |
| Cleaner, Ultrasonic, Medical Instrument | FLG | Class 1 | General Hospital | No | 2023-11-08 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2016-09-01 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2023-01-30 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2026-03-24 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2025-02-05 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2025-02-05 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2025-02-05 |
| Aligner, Bracket, Orthodontic | ECQ | Class 1 | Dental | No | 2024-03-05 |
Proprietary Names
EC CERTIFICATION
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility