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) (6) Abutment, implant, dental, endosseous (NHA) (1) System, image processing, radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

Simplant - 07392532191237 Catalog Number : 54500277O18

Device Description : Simplant OneShot

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Atlantis® - 07392532198830 Catalog Number :

Device Description : Atlantis Conus Base Ti

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Atlantis® - 07392532198847 Catalog Number :

Device Description : Atlantis Conus Hybrid Ti

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Atlantis® - 07392532198854 Catalog Number :

Device Description : Atlantis Conus Bridge Ti

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532204722 Catalog Number :

Device Description : Atlantis Healing Abutment

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ATLANTIS™ - 07392532204739 Catalog Number :

Device Description : Atlantis Healing Abutment GS

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

Atlantis - 07392532257339 Catalog Number :

Device Description : Atlantis Bridgebase Ti AM

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

DS - 07392532274664 Catalog Number :

Device Description : DS Milling Ti butment

Device Class : 2

Duns Number: 847337201

Premarket Exempt : No

Product Code : NHA

Prescription Use : No

Device Count : 1

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