VOCO GmbH

Address:ANTON-FLETTNER-STRASSE 1-3,CUXHAVEN Lower Saxony,DE

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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

Cement, Dental (EMA) (4) Liner, Cavity, Calcium Hydroxide (EJK) (3) Material, Tooth Shade, Resin (EBF) (2) Zinc Oxide Eugenol (EMB) (1)

Premarket Exempt

No Yes

Clear

Meron - E22110901 Catalog Number : 1090

Device Description : Glass ionomer luting cement.Low solubility in the mouth.Low acidity.Biocompatibl Glass ionomer luting cement.Low solubility in the mouth.Low acidity.Biocompatible.Easy application.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Calcicur - E22110931 Catalog Number : 1093

Device Description : Calcicur is a radiopaque, ready-to-use water-based calcium hydroxide paste witha Calcicur is a radiopaque, ready-to-use water-based calcium hydroxide paste witha pH value of >12.5.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

Calcimol - E22110971 Catalog Number : 1097

Device Description : Self-curing radiopaque calcium hydroxide paste.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

Provicol QM Plus - E22110981 Catalog Number : 1098

Device Description : Eugenol-free temporary luting cement with calcium hydroxide.

Device Class : 1

Duns Number: 316699578

Premarket Exempt : No

Product Code : EMB

Prescription Use : Yes

Device Count : 1

Provicol QM - E22110991 Catalog Number : 1099

Device Description : Eugenol-free temporary luting cement with calcium hydroxide.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Ceramic Bond - E22111061 Catalog Number :

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

Ceramic Bond - E22111071 Catalog Number :

Device Class :

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 50

Provicol QM Aesthetic - E22111081 Catalog Number : 1108

Device Description : Eugenol-free temporary luting cement with calcium hydroxide.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

Provicol QM - E22111091 Catalog Number : 1109

Device Description : Eugenol-free temporary luting cement with calcium hydroxide.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 3

Ionoseal - E22111261 Catalog Number : 1126

Device Description : Light-curing glass ionomer composite liner.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EJK

Prescription Use : Yes

Device Count : 1

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