VERSAH, LLC

Address:1600 Executive Dr,Jackson,MI,49203,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) Bur, Dental (EJL) (3) Cardiac Support Mesh Wrap (NAP) (2)

Premarket Exempt

Yes

Clear

Densah Bur - 00850017652101 Catalog Number :

Device Description : Densah Burs are indicated for use to prepare osteotomies for dental implant plac Densah Burs are indicated for use to prepare osteotomies for dental implant placement in the mandible and maxilla.

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 1

Densah Bur - 00850017652118 Catalog Number :

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 1

Tapered Pilot Drill - 00850017652125 Catalog Number :

Device Description : Tapered Pilot Drill is used to create the initial hold in bone to prepare an ost Tapered Pilot Drill is used to create the initial hold in bone to prepare an osteotomy for dental implant placement and monitor the drilling depth.

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : EJL

Prescription Use : Yes

Device Count : 1

Parallel Pin - 00850017652132 Catalog Number :

Device Description : For use as a paralleling guide with the Densah Burs

Device Class :

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : NAP

Prescription Use : Yes

Device Count : 1

Parallel Pin-Extra Large - 00850017652149 Catalog Number :

Device Description : For use as a paralleling guide with the Densah Burs

Device Class :

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : NAP

Prescription Use : Yes

Device Count : 1

Universal Bur Holder - 00850017652156 Catalog Number :

Device Description : a holding device in the surgical operatory for the Densah Burs, Tapered Pilot Dr a holding device in the surgical operatory for the Densah Burs, Tapered Pilot Drill and Parallel Pins

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

C-Guide-Small - 00850017652163 Catalog Number :

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

C-Guide-Medium - 00850017652170 Catalog Number :

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

C-Guide-Large - 00850017652187 Catalog Number :

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

C-Guide-Extra Large - 00850017652194 Catalog Number :

Device Class : 1

Duns Number: 081472844

Premarket Exempt : Yes

Product Code : NDP

Prescription Use : Yes

Device Count : 1

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