FDA Registration
Active
🇺🇸 United States
MEDENTAL INTL.
Reg #: 1723973
·
FEI: 3001236822
·
Expires 2026
Products
5
Proprietary Names
3
Establishment Types
2
Classifications
5
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Registration Details
- Registration Name
- MEDENTAL INTL.
- Registration Number
- 1723973
- FEI Number
- 3001236822
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 3008 PALM HILL DR.
- City
- VISTA
- State
- CA
- ZIP
- 92084
- Country
- US
Regulatory Submissions
- 510(k) Number
- K990314
Owner / Operator
- Firm Name
- MEDENTAL INTL.
- Operator Number
- 9030403
- Address
- 3008 PALM HILL DR., --
- City
- Vista
- State
- CA
- Postal Code
- 92084
- Country
- US
- Correspondent
- Jane S Mitchell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2008-03-20 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2012-04-15 |
| Varnish, Cavity | LBH | Class 2 | Dental | No | 2008-03-20 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2022-09-20 |
| Sealant, Pit And Fissure, And Conditioner | EBC | Class 2 | Dental | No | 2008-03-20 |
Proprietary Names
Medental
Medental Prophy Paste
Medental Pit and Fissure Sealant with Orhothophosphoric Acid (Conditioner)
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility