Rønvig Dental Manufacturing A/S

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Protector, Dental (BRW) (2) Syringe, Cartridge (EJI) (2) Handle, Instrument, Dental (EJB) (1) Airbrush (KOJ) (1) Injector, Jet, Mechanical-Powered (EGM) (1) Heat Source For Bleaching Teeth (EEG) (1) Drill, Dental, Intraoral (DZA) (1)

Premarket Exempt

No Yes

Clear

ASPIJECT - 05713513000010 Catalog Number :

Device Description : Self-aspirating dental injection syringe for 1.8 ml standard dental cartridges

Device Class : 2

Duns Number: 307549241

Premarket Exempt : No

Product Code : EJI

Prescription Use : No

Device Count : 1

PAROJECT - 05713513000058 Catalog Number :

Device Description : Intraligamental injection syringe

Device Class : 2

Duns Number: 307549241

Premarket Exempt : No

Product Code : EGM

Prescription Use : No

Device Count : 1

CONTA-GUARD - 05713513000089 Catalog Number :

Device Description : 200 pcs. of laminated disposable foil for protection against needle stick.

Device Class : 1

Duns Number: 307549241

Premarket Exempt : Yes

Product Code : BRW

Prescription Use : No

Device Count : 1

COMPO-JECT - 05713513000119 Catalog Number :

Device Description : Composite Applicator for delivery of dental materials in pre-filled unit-dose ti Composite Applicator for delivery of dental materials in pre-filled unit-dose tips for direct oral application.

Device Class : 1

Duns Number: 307549241

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : No

Device Count : 1

CTT CERAMIC TISSUE TRIMMER - 05713513000157 Catalog Number :

Device Description : A rotating instrument used for minor surgical procedures in dentistry.

Device Class : 1

Duns Number: 307549241

Premarket Exempt : Yes

Product Code : DZA

Prescription Use : No

Device Count : 1

DENTO PREP - 05713513000164 Catalog Number :

Device Description : Dental Micro-blaster for use with aluminium oxide powder.

Device Class : 2

Duns Number: 307549241

Premarket Exempt : No

Product Code : KOJ

Prescription Use : No

Device Count : 1

CONTA-GUARD - 05713513000362 Catalog Number :

Device Description : A autoclavable Recapping Stand for one-handed handling of injection needles to a A autoclavable Recapping Stand for one-handed handling of injection needles to avoid needle stick injuries.

Device Class : 1

Duns Number: 307549241

Premarket Exempt : Yes

Product Code : BRW

Prescription Use : No

Device Count : 1

CALAJECT - 05713513000942 Catalog Number :

Device Description : Computer-assisted dental injection syringe

Device Class : 2

Duns Number: 307549241

Premarket Exempt : Yes

Product Code : EJI

Prescription Use : No

Device Count : 1

EASE-IT - 05713513001000 Catalog Number :

Device Description : Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, desi Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials.

Device Class : 1

Duns Number: 307549241

Premarket Exempt : Yes

Product Code : EEG

Prescription Use : No

Device Count : 1

Previous 1 Next