Innovation MediTech GmbH

Address:MAX-PLANCK-STR. 31,UNNA North Rhine-Westphalia,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

Hearing aid, air conduction (ESD) (7) Coating, Filling Material, Resin (EBD) (3)

Premarket Exempt

No Yes

Clear

Sonopal® hard Lacquer Al - E239M1113001 Catalog Number : M111300

Device Description : No.

Device Class : 1

Duns Number: 313785693

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Sonopal® hard Lacquer Al - E239M1113031 Catalog Number : M111303

Device Description : No.

Device Class : 1

Duns Number: 313785693

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Sonopal® hard Lacquer Al - E239M1113041 Catalog Number : M111304

Device Description : No.

Device Class : 1

Duns Number: 313785693

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Sonopal® hard Lacquer Al - E239M1113091 Catalog Number : M111309

Device Description : No.

Device Class : 1

Duns Number: 313785693

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Sonopal® soft Lacquer E - E239M1115041 Catalog Number : M111504

Device Description : No.

Device Class : 1

Duns Number: 313785693

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Sonopal® soft Lacquer E - E239M1115051 Catalog Number : M111505

Device Description : No.

Device Class : 1

Duns Number: 313785693

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

Sonopal® soft Lacquer E - E239M1115071 Catalog Number : M111507

Device Description : No.

Device Class : 1

Duns Number: 313785693

Premarket Exempt : Yes

Product Code : ESD

Prescription Use : No

Device Count : 1

VITA ENAMIC GLAZE - E239M700101 Catalog Number : M70010

Device Description : Light-curing dental lacquer for final coating of shade customization/characteriz Light-curing dental lacquer for final coating of shade customization/characterization of the surface of dental restorations. 20 ml bottle.

Device Class : 2

Duns Number: 313785693

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

VITA ENAMIC STAINS LIQUID - E239M700111 Catalog Number : M70011

Device Description : Liquid for shade customization and characterization of the surface of dental res Liquid for shade customization and characterization of the surface of dental restorations,20 ml bottle.

Device Class : 2

Duns Number: 313785693

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

VITA ENAMIC STAIN white - E239M7001211 Catalog Number : M700121

Device Description : Colour powder for shade customization and characterization of the surface of den Colour powder for shade customization and characterization of the surface of dental restorations. 2 g bottle.

Device Class : 2

Duns Number: 313785693

Premarket Exempt : No

Product Code : EBD

Prescription Use : Yes

Device Count : 1

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