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, Contra- And Right-Angle Attachment, Dental (EGS) (5) Handpiece, Air-Powered, Dental (EFB) (4) Unit, Operative Dental (EIA) (1)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022654710 Catalog Number :

Device Description : 1:5 AC-L ATTACHMENT, ETORQUE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022654720 Catalog Number :

Device Description : 1:1 AL-L ATTACHMENT, ETORQUE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022654730 Catalog Number :

Device Description : 1:1 ST ATTACHMENT, ETORQUE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022654740 Catalog Number :

Device Description : 5:1 AL ATTACHMENT, ETORQUE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022654750 Catalog Number :

Device Description : 5:1 AL-L ATTACHMENT, ETORQUE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022656300 Catalog Number :

Device Description : CONCENTRIX MX

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022656330 Catalog Number :

Device Description : SIMPLICITY SW

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022656340 Catalog Number :

Device Description : SIMPLICITY FX

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022656460 Catalog Number :

Device Description : LED PLUG 'N PLAY SWIVEL ASSY

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022656760 Catalog Number :

Device Description : STARBRIGHT DUAL LAMP CONTROL SYSTEM

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

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