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) (8) Alloy, amalgam (EJJ) (2)

Premarket Exempt

No Yes

Clear

Celtra® DUO Blocks - D00253654112551 Catalog Number : 5365411255

Device Description : Celtra® DUO CEREC&INLAB HT 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 - D00253654112651 Catalog Number : 5365411265

Device Description : Celtra® DUO CEREC&INLAB HT 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 - D00253654112951 Catalog Number : 5365411295

Device Description : Celtra® DUO CEREC&INLAB HT 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 - D00253654113051 Catalog Number : 5365411305

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

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654113351 Catalog Number : 5365411335

Device Description : Celtra® DUO CEREC&INLAB HT D2 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654113451 Catalog Number : 5365411345

Device Description : Celtra® DUO CEREC&INLAB HT D3 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654113751 Catalog Number : 5365411375

Device Description : Celtra® DUO CEREC&INLAB HT BL2 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Celtra® DUO Blocks - D00253654113851 Catalog Number : 5365411385

Device Description : Celtra® DUO CEREC&INLAB HT BL3 C14, 4-Block Refill

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 4

Megalloy®EZ Spherical Amalgam - D0026030041 Catalog Number : 603004

Device Description : Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 1 Spill (Red)

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

Megalloy®EZ Spherical Amalgam - D0026030051 Catalog Number : 603005

Device Description : Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 2 Spill (Purple)

Device Class :

Duns Number: 083235549

Premarket Exempt : No

Product Code : EJJ

Prescription Use : Yes

Device Count : 50

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