FDA Registration
Active
🇺🇸 United States
OPA DENTAL, LLC
Reg #: 3008582406
·
FEI: 3008582406
·
Expires 2026
Products
13
Proprietary Names
4
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- OPA DENTAL, LLC
- Registration Number
- 3008582406
- FEI Number
- 3008582406
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 105 Whitaker blvd
- City
- Huntington
- State
- WV
- ZIP
- 25701
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181167
Owner / Operator
- Firm Name
- Opa Dental, LLC
- Operator Number
- 10033786
- Address
- 105 Whitaker blvd
- City
- Huntington
- State
- WV
- Postal Code
- 25701
- Country
- US
- Correspondent
- Lee Gorham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2021-02-05 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2021-04-14 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2015-12-15 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2023-12-05 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2018-11-06 |
| Wheel, Polishing Agent | EJQ | Class 1 | Dental | No | 2013-08-07 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 2013-08-07 |
| Disk, Abrasive | EHJ | Class 1 | Dental | No | 2013-08-07 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2018-10-19 |
| Material, Impression | ELW | Class 2 | Dental | No | 2018-09-18 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2021-06-03 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2013-08-07 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2018-10-19 |
Proprietary Names
Ceramic grinder
Rubber polisher
Silicone polisher
diamond burs
Establishment Types
Repack or Relabel Medical Device