Cavex Holland B.V.

Address:FUSTWEG 5,HAARLEM Noord-Holland,NL

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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

Disinfectant, Medical Devices (LRJ) (3) Cleanser, Denture, Over The Counter (EFT) (2) Syringe, Periodontic, Endodontic, Irrigating (EIC) (2) Cement, Dental (EMA) (1) Toothbrush, Manual (EFW) (1) Wax, Dental, Intraoral (EGD) (1)

Premarket Exempt

Yes No

Clear

Cavex Temporary Cement - E241CE0900 Catalog Number : CE090

Device Description : Dental Cement

Device Class : 2

Duns Number: 419980156

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Cavex GreenClean - E241HA0010 Catalog Number : HA010

Device Description : Dental cleaning agent

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : EFT

Prescription Use : No

Device Count : 1

Cavex GreenClean sample - E241HA0030 Catalog Number : HA003

Device Description : Dental cleaning agent

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : EFT

Prescription Use : No

Device Count : 1

Cavex ImpreSafe refills - E241HA0500 Catalog Number : HA050

Device Description : Dental impression disinfectant

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Cavex ImpreSafe starterkit - E241HA0530 Catalog Number : HA053

Device Description : Dental impression disinfectant

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Cavex RushBrush - E241HA0900 Catalog Number : HA090

Device Description : Tooth Brush, Manual

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : EFW

Prescription Use : No

Device Count : 1

Cavex ImpreSafe container - E241HT0200 Catalog Number : HT020

Device Description : Dental impression disinfectant

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

Cavex Vibringe - E241VI0010 Catalog Number : VI001

Device Description : Edodontic Irrigating Device

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : EIC

Prescription Use : No

Device Count : 1

Cavex Vibringe - E241VI0110 Catalog Number : VI011

Device Description : Edodontic Irrigating Device

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : EIC

Prescription Use : No

Device Count : 1

Cavex Set Up Soft Modelling Wax - E241WA0040 Catalog Number : WA004

Device Description : Dental Wax

Device Class : 1

Duns Number: 419980156

Premarket Exempt : Yes

Product Code : EGD

Prescription Use : No

Device Count : 1

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