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) (10)

Premarket Exempt

No Yes

Clear

ACT® - 00844868000358 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 3.85MM(D) X 20MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000365 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 4.25MM(D) X 13MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000372 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 4.25MM(D) X 18MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000389 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 4.25MM(D) X 8.5MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000396 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 4.85MM(D) X 13MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000402 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 4.85MM(D) X 18MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000419 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 4.85MM(D) X 8.5MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000426 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 5.25MM(D) X 13MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000433 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 5.25MM(D) X 18MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

ACT® - 00844868000440 Catalog Number :

Device Description : ADVANCED CUTTING TECHNOLOGY® (ACT®) TWIST DRILL 5.25MM(D) X 8.5MM(L)

Device Class : 1

Duns Number: 186127825

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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