FDA Registration
Active
🇺🇸 United States
DENTAMERICA
Reg #: 2024949
·
FEI: 2024949
·
Expires 2026
Products
21
Proprietary Names
13
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- DENTAMERICA
- Registration Number
- 2024949
- FEI Number
- 2024949
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18688 SAN JOSE AVE
- City
- City of Industry
- State
- CA
- ZIP
- 91748
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120106
Owner / Operator
- Firm Name
- DENTAMERICA
- Operator Number
- 2024949
- Address
- 18688 SAN JOSE AVE
- City
- City of Industry
- State
- CA
- Postal Code
- 91748
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Extraoral Source, Digital | MUH | Class 2 | Dental | No | 2026-04-21 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2007-11-29 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2004-07-23 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2015-11-12 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2001-12-04 |
| Holder, Film, X-Ray | EGZ | Class 1 | Dental | No | 2010-09-27 |
| Instrument, Hand, Calculus Removal | ELA | Class 1 | Dental | No | 2001-12-04 |
| Handpiece, Direct Drive, Ac-Powered | EKX | Class 1 | Dental | No | 2010-02-04 |
| Film, Radiographic | IWZ | Class 1 | Radiology | No | 2010-09-27 |
| Cup, Prophylaxis | EHK | Class 1 | Dental | No | 2001-12-04 |
| Light, Operating, Dental | EAZ | Class 1 | Dental | No | 2012-07-10 |
| File, Pulp Canal, Endodontic | EKS | Class 1 | Dental | No | 2015-11-12 |
| Light, Fiber Optic, Dental | EAY | Class 1 | Dental | No | 2001-12-04 |
| Aligner, Beam, X-Ray | EHA | Class 1 | Dental | No | 2010-09-27 |
| Unit, X-Ray, Extraoral With Timer | EHD | Class 2 | Dental | No | 2007-11-29 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2024-02-06 |
| Unit, Operative Dental, Accessories | NRD | Class 1 | Dental | No | 2012-07-10 |
| Material, Impression | ELW | Class 2 | Dental | No | 2007-11-29 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2010-06-21 |
| Illuminator, Radiographic-Film | IXC | Class 1 | Radiology | No | 2005-10-25 |
| Scaler, Ultrasonic | ELC | Class 2 | Dental | No | 2007-11-29 |
Proprietary Names
APIXIA DIGIREX
CAMMY
EVERBRITE
DENTAL BUR
POLYBITE
DENTAMERICA
CELUX
ENDO FILE
LITEX
POLYMAS Mouth Mirror & Accessories, Dental Hand Instrument, Mirror Defogging System
LYGIN
TELEREX
SCALEX
Establishment Types
Repack or Relabel Medical Device