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) (6) ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS (NHA) (3) Accessories, implant, dental, endosseous (NDP) (1)

Premarket Exempt

No Yes

Clear

NA - 00844868000150 Catalog Number :

Device Description : CONICAL 25° 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

NA - 00844868000167 Catalog Number :

Device Description : CONICAL 17° ANGLED ABUTMENT 4.1MM(D) X 4MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

NA - 00844868000174 Catalog Number :

Device Description : CONICAL 25° ANGLED ABUTMENT 4.1MM(D) X 4MM(H)

Device Class : 2

Duns Number: 186127825

Premarket Exempt : No

Product Code : NHA

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000181 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 2.0MM(D) X 10MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000198 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 2.0MM(D) X 15MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000204 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 2.0MM(D) X 20MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000211 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 2.75MM(D) X 10MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000228 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 2.75MM(D) X 15MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000235 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 2.75MM(D) X 20MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000242 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 3.0MM(D) X 10MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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