FDA Registration
Active
🇺🇸 United States
TANGENT ORTHODONTICS
Reg #: 3015259864
·
FEI: 3015259864
·
Expires 2026
Products
10
Proprietary Names
10
Establishment Types
3
Classifications
10
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Registration Details
- Registration Name
- TANGENT ORTHODONTICS
- Registration Number
- 3015259864
- FEI Number
- 3015259864
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2165 Earlywood Drive
- City
- Franklin
- State
- IN
- ZIP
- 46131
- Country
- US
Regulatory Submissions
- 510(k) Number
- K182672
Owner / Operator
- Firm Name
- Tangent Technologies LLC
- Operator Number
- 10059559
- Address
- 2165 Earlywood Drive
- City
- Franklin
- State
- IN
- Postal Code
- 46131
- Country
- US
- Correspondent
- Brandon Bernacchi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2020-04-23 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2024-12-18 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2024-04-04 |
| Bracket, Ceramic, Orthodontic | NJM | Class 2 | Dental | No | 2024-12-18 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2019-01-31 |
| Clamp, Wire, Orthodontic | ECN | Class 1 | Dental | No | 2024-12-18 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2024-12-18 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2024-12-18 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2024-12-18 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2024-12-18 |
Proprietary Names
Elastic Separators; Elastic Thread; Elastics; Energy Chain; Elastomeric Ligatures; Rotation Wedge
Orthodontic Metal Brackets
Patient Relief Wax
Ceramic Orthodontic Brackets
Orthodontic Wire and Archwires-Beta Titanium (Beta Ti); Nickel Titanium (NiTi) ; Stainless Steel (SS) ; Nickel Cobalt
Bondable Button: Eruption Appliance, Crimpable Stop, Crimpable Hook,
Orthodontic Buccal Tubes and Orthodontic Metal Tubes
Orthodontic Springs- Nickel Titanium (NiTi) ; Stainless Steel (SS) : Nickel Cobalt
Impression Tray
Orthodontic Bands
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device