DENTSPLY IH, INC.

DENTSPLY IH, INC.

Address:590 LINCOLN STREET,North Waltham,MA,02451,US

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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

ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS (NHA) (8) Accessories, implant, dental, endosseous (NDP) (1) POWDER, PORCELAIN (EIH) (1)

Premarket Exempt

No Yes

Clear

ATLANTIS™ - 07392532083426 Catalog Number :

Device Description : ATLANTIS Abutment Zr 00

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532083433 Catalog Number :

Device Description : ATLANTIS Abutment Ti

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532083440 Catalog Number :

Device Description : ATLANTIS Abutm Goldshaded Ti

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532083457 Catalog Number :

Device Description : ATLANTIS Abutment Ti Duplicate

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532083464 Catalog Number :

Device Description : ATLANTIS Abutm Goldsh Ti Dup

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

SIMPLANT® - 07392532177064 Catalog Number :

Device Description : SIMPLANT Guide

Device Class : 1

Duns Number: 847337201

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532177088 Catalog Number :

Device Description : Atlantis Abutment Screw

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532177101 Catalog Number :

Device Description : ATLANTIS Crown

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532177118 Catalog Number :

Device Description : ATLANTIS Conus Abutm OD Ti

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532177125 Catalog Number :

Device Description : ATLANTIS Conus Abutm OD Ti Dup

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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