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) (7) ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS (NDP) (2) IMPLANT, ENDOSSEOUS, ROOT-FORM (DZE) (1)

Premarket Exempt

No Yes

Clear

ACT® - 00844868000457 Catalog Number :

Device Description : ACT® DRILL EXTENSION

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000464 Catalog Number :

Device Description : ACT® POINTED STARTER DRILL

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

NA - 00844868000495 Catalog Number :

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

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

PREP-TITE® - 00844868000518 Catalog Number :

Device Description : PREP-TITE® POST 4.1MM(D) X 5MM(P) X 2MM(H) WITH TI HEXED SCREW

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : DZE

Prescription Use : Yes

Device Count : 1

GINGIHUE® - 00844868000525 Catalog Number :

Device Description : GINGIHUE® POST 4.1MM(D) X 5MM(P) X 2MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

GINGIHUE® - 00844868000532 Catalog Number :

Device Description : GINGIHUE® POST 4.1MM(D) X 5MM(P) X 4MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

GINGIHUE® - 00844868000549 Catalog Number :

Device Description : GINGIHUE® POST 4.1MM(D) X 6MM(P) X 2MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

GINGIHUE® - 00844868000556 Catalog Number :

Device Description : GINGIHUE® POST 4.1MM(D) X 6MM(P) X 4MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

GINGIHUE® - 00844868000563 Catalog Number :

Device Description : GINGIHUE® POST 4.1MM(D) X 7.5MM(P) X 2MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

GINGIHUE® - 00844868000570 Catalog Number :

Device Description : GINGIHUE® POST 4.1MM(D) X 7.5MM(P) X 4MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

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