DENTSPLY INTERNATIONAL INC.

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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

POWDER, PORCELAIN (EIH) (10)

Premarket Exempt

No Yes

Clear

Celtra® DUO Blocks - D00253654110051 Catalog Number : 5365411005

Device Description : Celtra® DUO SRNA LT A1 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654110111 Catalog Number : 5365411011

Device Description : Celtra® DUO SRNA LT A2 C14 1ST-SM

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

Celtra® DUO Blocks - D00253654110151 Catalog Number : 5365411015

Device Description : Celtra® DUO SRNA LT A2 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654110211 Catalog Number : 5365411021

Device Description : Celtra® DUO SRNA LT A3 C14 1ST-SM

Device Class : 2

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

Celtra® DUO Blocks - D00253654110251 Catalog Number : 5365411025

Device Description : Celtra® DUO SRNA LT A3 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654110351 Catalog Number : 5365411035

Device Description : Celtra® DUO SRNA LT A3.5 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654110551 Catalog Number : 5365411055

Device Description : Celtra® DUO CEREC&INLAB LT B1 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654110651 Catalog Number : 5365411065

Device Description : Celtra® DUO SRNA LT B2 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654110951 Catalog Number : 5365411095

Device Description : Celtra® DUO CEREC&INLAB LT C1 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654111051 Catalog Number : 5365411105

Device Description : Celtra® DUO CEREC&INLAB LT C2 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

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