DENTALEZ, INC.

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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

Handpiece, Air-Powered, Dental (EFB) (8) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (2)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022661320 Catalog Number :

Device Description : Titan-E 20K Motor (Fixed Backend)

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661340 Catalog Number :

Device Description : BB LATCH ANGLE, TITAN EX

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661530 Catalog Number :

Device Description : 430 SWL FLEX, LUBE FREE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661540 Catalog Number :

Device Description : 430 SWL FLEX, LUBRICATED

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661820 Catalog Number :

Device Description : 430SWL RA LUBEFREE HANDPIECE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661830 Catalog Number :

Device Description : 430SWL RA LUBRICATED HANDPIECE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662120 Catalog Number :

Device Description : 430 SWL TORQUE FLEX, LUBRICATED

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662130 Catalog Number :

Device Description : 430 TORQUE FLEX, FO, LUBE FREE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662450 Catalog Number :

Device Description : Aeras 400 Flex Handpiece, LubeFree, Fiber Optic

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662600 Catalog Number :

Device Description : Aeras 400 Flex Handpiece, LubeFree, non-Fiber Optic

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

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