FDA Registration
Active
🇩🇰 Denmark
RONVIG DENTAL MFG. A/S
Reg #: 9613230
·
FEI: 3002808025
·
Expires 2026
Products
9
Proprietary Names
11
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- RONVIG DENTAL MFG. A/S
- Registration Number
- 9613230
- FEI Number
- 3002808025
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- GL. VEJLEVEJ 59
- City
- DAUGAARD Midtjylland
- Country
- DK
Regulatory Submissions
- 510(k) Number
- K161869
Owner / Operator
- Firm Name
- RONVIG DENTAL MFG. A/S
- Operator Number
- 9029460
- Address
- GL. VEJLEVEJ 59, --
- City
- DAUGAARD
- State
- DK-NOTA
- Postal Code
- 8721
- Country
- DK
- Correspondent
- Annette R Nielsen
US Agent
- Business Name
- Parkell
- Contact Name
- Yasily Ogando Roa
- Address
- 300 Executive Dr
- City
- Edgewood
- State
- NY
- ZIP
- 11717
- Country
- US
- [email protected]
- Phone
- 631 3891560
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Syringe, Cartridge | EJI | Class 2 | Dental | No | 2017-09-26 |
| Protector, Dental | BRW | Class 1 | Anesthesiology | No | 2011-05-03 |
| Injector, Jet, Mechanical-Powered | EGM | Class 2 | Dental | No | 2009-10-28 |
| Unit, Oral Irrigation | EFS | Class 1 | Dental | No | 2000-07-14 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2004-02-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2010-08-30 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2001-07-20 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2000-07-14 |
| Airbrush | KOJ | Class 2 | Dental | No | 2007-12-12 |
Proprietary Names
CALAJECT
CONTA-GUARD
PAROJECT
AQUA-PRESS
EASE-IT
FLEXI-TRIX
FLEXI-CLAMP
COMPO-JECT COMPOSITE APPLICATOR
ASPIJECT
CTT CERAMIC TISSUE TRIMMER
Dento Prep
Establishment Types
Manufacture Medical Device