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

Composite Resin Warmer (QGO) (3) Cement, Dental (EMA) (2) Handle, Instrument, Dental (EJB) (2) Activator, Ultraviolet, For Polymerization (EBZ) (1) Dental Barriers And Sleeves (PEM) (1)

Premarket Exempt

No Yes

Clear

VisCalor Dispenser - E22191441 Catalog Number :

Device Description : Preheating dispenser for composite Caps - Caps mount

Device Class :

Duns Number: 316699578

Premarket Exempt : Yes

Product Code : QGO

Prescription Use : Yes

Device Count : 2

VisCalor Dispenser - E22191451 Catalog Number :

Device Description : Preheating dispenser for composite Caps - protective cover

Device Class :

Duns Number: 316699578

Premarket Exempt : Yes

Product Code : PEM

Prescription Use : Yes

Device Count : 100

VisCalor Dispenser - E22191461 Catalog Number :

Device Description : Preheating dispenser for composite Caps

Device Class : 1

Duns Number: 316699578

Premarket Exempt : Yes

Product Code : QGO

Prescription Use : Yes

Device Count : 1

Activator AC - E22193001 Catalog Number :

Device Class : 1

Duns Number: 316699578

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : Yes

Device Count : 1

Dispenser - E22193011 Catalog Number :

Device Description : Dispenser Caps

Device Class : 1

Duns Number: 316699578

Premarket Exempt : Yes

Product Code : EJB

Prescription Use : Yes

Device Count : 1

VisCalor Dispenser - E22199951 Catalog Number :

Device Description : Preheating dispenser for composite Caps, repaired

Device Class : 1

Duns Number: 316699578

Premarket Exempt : Yes

Product Code : QGO

Prescription Use : Yes

Device Count : 1

Celalux 3 - E22199961 Catalog Number : 9996

Device Description : Celalux 3, repaired

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBZ

Prescription Use : Yes

Device Count : 1

Meron - E222112421 Catalog Number : 1242

Device Description : Dual-curing universal composite-based luting system.For all materials (metal, co

Device Class :

Duns Number: 316699578

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 50

IonoStar Molar - E2225241 Catalog Number : 2524

Device Description : Glas ionomer restorative material.

Device Class :

Duns Number: 316699578

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 20

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