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

ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (5) ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS (NHA) (3) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (2)

Premarket Exempt

No Yes

Clear

NA - 00844868000730 Catalog Number :

Device Description : WIDE DIAMETER BONE PROFILER KIT 5MM & 6MM(D)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000747 Catalog Number :

Device Description : ORGANIZER BOX FOR WIDE DIAMETER BONE PROFILER KIT

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000754 Catalog Number :

Device Description : GUIDE FOR BONE PROFILER

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000761 Catalog Number :

Device Description : STANDARD DIAMETER BONE PROFILER KIT 4.1MM(D)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000778 Catalog Number :

Device Description : ORGANIZER BOX FOR STANDARD DIAMETER BONE PROFILER KIT

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000785 Catalog Number :

Device Description : CONICAL ABUTMENT 4.1MM(D) X 1MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NA - 00844868000792 Catalog Number :

Device Description : CONICAL ABUTMENT SCREW 4.1 & 5MM(D) X 1MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

NA - 00844868000808 Catalog Number :

Device Description : CONICAL 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 - 00844868000815 Catalog Number :

Device Description : CONICAL ABUTMENT SCREW 4.1 & 5MM(D) X 2MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

NA - 00844868000822 Catalog Number :

Device Description : CONICAL 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

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