BIOMET 3I, LLC

Address:4555 Riverside Drive,Palm Beach Gardens,FL,33410,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) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (4)

Premarket Exempt

No Yes

Clear

NA - 00844868000051 Catalog Number :

Device Description : STANDARD ABUTMENT 4.1MM(D) X 2MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NA - 00844868000068 Catalog Number :

Device Description : STANDARD ABUTMENT TITANIUM SCREW 2MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

NA - 00844868000075 Catalog Number :

Device Description : STANDARD ABUTMENT 4.1MM(D) X 3MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NA - 00844868000082 Catalog Number :

Device Description : STANDARD ABUTMENT TITANIUM SCREW 3MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

NA - 00844868000099 Catalog Number :

Device Description : STANDARD ABUTMENT 4.1M(D) X 4MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NA - 00844868000105 Catalog Number :

Device Description : STANDARD ABUTMENT TITANIUM SCREW 4MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

NA - 00844868000112 Catalog Number :

Device Description : STANDARD ABUTMENT 4.1MM(D) X 5.5MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NA - 00844868000129 Catalog Number :

Device Description : STANDARD ABUTMENT TITANIUM SCREW 5.5MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

NA - 00844868000136 Catalog Number :

Device Description : STANDARD ABUTMENT 4.1MM(D) X 7MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NA - 00844868000143 Catalog Number :

Device Description : CONICAL 17° ANGLED ABUTMENT 4.1MM(D) X 2MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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