Data / Medical devices / Denmark / Ronvig Dental MFG. A/S
Ronvig Dental MFG. A/S: FDA-registered device maker in DAUGAARD Midtjylland, Denmark, 3 510(k) clearances
Ronvig Dental MFG. A/S is registered with the FDA (registration 9613230) in DAUGAARD Midtjylland, Denmark. It lists 9 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 10, 2001. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613230
- FEI number
- 3002808025
- Address
- GL. Vejlevej 59, DAUGAARD Midtjylland, Denmark, 8721
- Owner or operator
- RONVIG DENTAL MFG. A/S (9029460)
- Roles
- Manufacturer
- First device listed
- July 14, 2000
- Registered through
- 2026
- Brand names listed
- AQUA-PRESS, ASPIJECT, CALAJECT, COMPO-JECT COMPOSITE APPLICATOR, CONTA-GUARD, CTT CERAMIC TISSUE TRIMMER, Dento Prep, EASE-IT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Airbrush | KOJ | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Heat Source For Bleaching Teeth | EEG | 1 | Manufacturer | accessdata.fda.gov |
| Injector, Jet, Mechanical-Powered | EGM | 2 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Manufacturer | accessdata.fda.gov |
| Protector, Dental | BRW | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Cartridge | EJI | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 10, 2001 | K010816 | DENTO-PREP PARTICLE MICROBLASTER | KOJ | Substantially Equivalent | Ronvig A/S | accessdata.fda.gov |
| October 13, 2000 | K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | EJI | Substantially Equivalent | Ronvig Instruments, Ltd. | accessdata.fda.gov |
| December 7, 1990 | K904279 | PAROJECT ANESTHETIC SYRINGE | EGM | Substantially Equivalent | Ronvig Instruments, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Injector, Jet, Mechanical-Powered
- All makers of Drill, Dental, Intraoral
- All makers of Airbrush
- All makers of Unit, Oral Irrigation
- All makers of Syringe, Cartridge
- All makers of Protector, Dental
Updated May 10, 2001. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.