Manufacturer registered with FDA
Ronvig Dental Mfg. A/S
DAUGAARD, Denmark. Lists 8 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 8
- Brands and models
- 10
- 510(k) clearances
- 12006–2006
- Markets registered in
- 415 registrations outside the US
- Establishments
- 1Denmark
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Ronvig Dental Mfg. A/S as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Ronvig Dental Mfg. A/S | 1 clearances | 2006–2006 | Below |
| United Kingdom | MHRA | Manufacturer | Ronvig Dental Mfg A/S | 13 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | RONVIG Dental Mfg. A/S | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Ronvig Dental Mfg. A/S | 1 | 2015–2015 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Ronvig Dental Mfg. A/S currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | ASPIJECTCALAJECT | 2007 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | CTT CERAMIC TISSUE TRIMMER | 2000 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | FLEXI-CLAMPFLEXI-TRIX | 2010 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | EASE-IT | 2004 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | AQUA-PRESS | 2000 |
| Mechanical-Powered Jet InjectorEGM · Class 2 | — | Maker | PAROJECT | 2009 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | COMPO-JECT COMPOSITE APPLICATOR | 2001 |
| AirbrushKOJ · Class 2 | — | Maker | Dento Prep | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Ronvig Dental Mfg. A/S lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Ronvig A/S (1), Ronvig Instruments, Ltd. (1), Ronvig Instruments, Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 10 May 2001 | K010816 | DENTO-PREP PARTICLE MICROBLASTER | Ronvig A/S | KOJ Airbrush |
| 13 Oct 2000 | K002168 | ASPIJECT SELF-ASPIRATING DENTAL INJECTION SYRINGE | Ronvig Instruments, Ltd. | EJI Cartridge Syringe |
| 7 Dec 1990 | K904279 | PAROJECT ANESTHETIC SYRINGE | Ronvig Instruments, Ltd. | EGM Mechanical-Powered Jet Injector |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RONVIG DENTAL MFG. A/SFDA reg. 9613230 | DAUGAARD Midtjylland, Denmark | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9029460). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.