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

Material, Tooth Shade, Resin (EBF) (6) Mouthguard, Prescription (MQC) (2) Positioner, Tooth, Preformed (KMY) (1) Resin, Denture, Relining, Repairing, Rebasing (EBI) (1)

Premarket Exempt

No Yes

Clear

VisCalor - E22161211 Catalog Number : 6121

Device Description : VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 16

VisCalor - E22161221 Catalog Number : 6122

Device Description : VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 16

VisCalor - E22161231 Catalog Number : 6123

Device Description : VisCalor is a light-curing, radiopaque, nano-hybrid restorative material.

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 16

V-Print splint comfort - E22161261 Catalog Number : 6126

Device Description : V-Print splint comfort is a light-curing resin for the generative manufacturing V-Print splint comfort is a light-curing resin for the generative manufacturing of thermoflexible splints (including therapeutic splints) as well as thermoflexible auxillary parts and functional parts for derntal diagnostics using CAD/CAM technology.

Device Class : U

Duns Number: 316699578

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

V-Print SG - E22161311 Catalog Number : 6131

Device Description : V-Print SG is a light-curing acrylic for the generative production of biocompati V-Print SG is a light-curing acrylic for the generative production of biocompatible dentaldrilling templates.

Device Class : 1

Duns Number: 316699578

Premarket Exempt : Yes

Product Code : KMY

Prescription Use : Yes

Device Count : 1

V-Print dentbase - E2216136 Catalog Number : 6136

Device Description : V-Print dentbase is a light-curing resin for the generative manufacture of dentu V-Print dentbase is a light-curing resin for the generative manufacture of denture bases forremovable prostheses using CAD/CAM technology, 200g bottle sample

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

V-Print splint comfort - E22161391 Catalog Number : 6139

Device Description : V-Print splint comfort is a light-curing resin for the generative manufacture of V-Print splint comfort is a light-curing resin for the generative manufacture of thermoflexible splints (including therapeutic splints) as well as thermoflexible auxiliary parts and functional parts for dental diagnostics using CAD/CAM technology.

Device Class : U

Duns Number: 316699578

Premarket Exempt : No

Product Code : MQC

Prescription Use : Yes

Device Count : 1

Grandio blocs - E22161531 Catalog Number : 6153

Device Description : 5x Gr. 12 A1 LT (Low Translucent)

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 5

Grandio blocs - E2216154 Catalog Number : 6154

Device Description : 5x Gr. 12 A2 LT (Low Translucent)

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 5

Grandio blocs - E22161551 Catalog Number : 6155

Device Description : 5x Gr. 12 A3 LT (Low Translucent)

Device Class : 2

Duns Number: 316699578

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 5

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