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) (3) Unit, Operative Dental (EIA) (1)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022656770 Catalog Number :

Device Description : STARBRIGHT SINGLE LAMP CONTROL SYSTEM

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022657180 Catalog Number :

Device Description : SOLARA QT LF FO HP

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D702265718F0 Catalog Number :

Device Description : SOLARA QT LF FO HP FUCHSIA COLLAR

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D702265718G0 Catalog Number :

Device Description : SOLARA QT LF FO HP GREEN COLLAR

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D702265718Y0 Catalog Number :

Device Description : SOLARA QT LF FO HP GOLD COLLAR

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022657210 Catalog Number :

Device Description : 430SWL HP AND TURBINE COMBO PACK

Device Class :

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022657910 Catalog Number :

Device Description : SOLARA QT FO HP LUBRICATED

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022658010 Catalog Number :

Device Description : TITAN 3 LF 5 STAR PROPHY ANGLE LH

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022658020 Catalog Number :

Device Description : TITAN-T 5 STAR PROPHY ANGLE LH

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022658060 Catalog Number :

Device Description : RPM PROPHY ANGLE LH

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

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