FDA Registration
Active
🇺🇸 United States
HEXA DENTAL
Reg #: 3014615644
·
FEI: 3014615644
·
Expires 2026
Products
22
Proprietary Names
6
Establishment Types
3
Classifications
22
Registration Details
- Registration Name
- HEXA DENTAL
- Registration Number
- 3014615644
- FEI Number
- 3014615644
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5211 E. Washington Blv. #2-201
- City
- Commerce
- State
- CA
- ZIP
- 90040
- Country
- US
Regulatory Submissions
- 510(k) Number
- K183424
Owner / Operator
- Firm Name
- HEXA Dental
- Operator Number
- 10059459
- Address
- 5211 E. Washington Blv. #2-201
- City
- Commerce
- State
- CA
- Postal Code
- 90040
- Country
- US
- Correspondent
- Faraz Rad
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2023-03-03 |
| Syringe, Restorative And Impression Material | EID | Class 1 | Dental | No | 2024-07-02 |
| Material, Impression | ELW | Class 2 | Dental | No | 2020-09-17 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2020-09-18 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | Class 2 | General, Plastic Surgery | No | 2020-09-18 |
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2020-09-18 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | Class 2 | General, Plastic Surgery | No | 2020-09-18 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2020-09-18 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2020-09-18 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2023-03-03 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2023-03-03 |
| Vapocoolant Device | MLY | Class U | Unknown | No | 2024-12-18 |
| Syringe, Piston | FMF | Class 2 | General Hospital | No | 2023-03-28 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2023-09-18 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2020-09-17 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2023-09-18 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2023-09-19 |
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2024-07-02 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2019-01-28 |
| Non-Surgical Gown | OEA | Class 1 | General, Plastic Surgery | No | 2020-10-19 |
| Diammine Silver Fluoride Dental Hypersensitivity Varnish | PHR | Class 2 | Dental | No | 2021-05-07 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2021-04-19 |
Proprietary Names
HEXA
Hexa Freeze
Hexa Composite
Hexa
Hexa Bonding
Dental Cement
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only