IVOCLAR VIVADENT AKTIENGESELLSCHAFT

IVOCLAR VIVADENT AKTIENGESELLSCHAFT

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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) RESIN, DENTURE, RELINING, REPAIRING, REBASING (EBI) (4)

Premarket Exempt

No Yes

Clear

ProBase Hot / ProBase Cold - 07615208006094 Catalog Number : 531471

Device Description : ProBase Hot Monomer 500 ml

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ProBase Hot / ProBase Cold - 07615208006100 Catalog Number : 531472

Device Description : ProBase Hot Monomer 1000 ml

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ProBase Hot / ProBase Cold - 07615208006117 Catalog Number : 531505

Device Description : ProBase Cold Monomer 500 ml

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

ProBase Hot / ProBase Cold - 07615208006124 Catalog Number : 531506

Device Description : ProBase Cold Monomer 1000 ml

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBI

Prescription Use : Yes

Device Count : 1

SR Nexco - 07615208006162 Catalog Number : 640401

Device Description : SR Nexco Paste Margin 2.5 g 1

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SR Nexco - 07615208006179 Catalog Number : 640402

Device Description : SR Nexco Paste Margin 2.5 g 2

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SR Nexco - 07615208006186 Catalog Number : 640403

Device Description : SR Nexco Paste Margin 2.5 g 3

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SR Nexco - 07615208006193 Catalog Number : 640404

Device Description : SR Nexco Paste Margin 2.5 g 4

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SR Nexco - 07615208006209 Catalog Number : 640405

Device Description : SR Nexco Paste Margin 2.5 g 5

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

SR Nexco - 07615208006216 Catalog Number : 640406

Device Description : SR Nexco Paste Dentin 2.5 g A1

Device Class : 2

Duns Number: 448015938

Premarket Exempt : No

Product Code : EBF

Prescription Use : Yes

Device Count : 1

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