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) (6) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (4)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022662700 Catalog Number :

Device Description : AERAS TITAN 5K MOTOR SW

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662710 Catalog Number :

Device Description : AERAS TITAN 20K MOTOR SW

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662750 Catalog Number :

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

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662760 Catalog Number :

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

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662790 Catalog Number :

Device Description : AERAS TITAN 5K MOTOR FX

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662800 Catalog Number :

Device Description : AERAS TITAN 20K MOTOR FX

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022662810 Catalog Number :

Device Description : Prophy Star 3 SW

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022688400 Catalog Number :

Device Description : 430SWL SATIN LF(SOLID F.O. ROD) HANDPIECE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022688410 Catalog Number :

Device Description : 430 SW SATIN LF HANDPIECE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutionss - D7022688420 Catalog Number :

Device Description : HiFlo 6-Pin Swivel, 3.3 Volts Satin

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

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