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) (5) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (5)

Premarket Exempt

Yes No

Clear

StarDental - D7022660410 Catalog Number : 266041

Device Description : Aeras 500 Elite Handpiece, LubeFree non Fiber Optic

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental - D7022660640 Catalog Number :

Device Description : Aeras 500 Swivel, Fiber Optic

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental - D7022660650 Catalog Number :

Device Description : Aeras 500 Swivel, non-Fiber Optic

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental - D7022660710 Catalog Number : 266071

Device Description : Aeras 500 Elite Handpiece, Lubricated, Fiber Optic

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental - D7022660720 Catalog Number :

Device Description : Aeras 500 Elite 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 - D7022661000 Catalog Number :

Device Description : Titan EX Motor 20K, 2-Line

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661010 Catalog Number :

Device Description : Titan EX Motor 20K, 4-Line

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661020 Catalog Number :

Device Description : 1:1 CONTRA ANGLE (MTAA), TITAN EX

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661030 Catalog Number :

Device Description : STRAIGHT NOSECONE, TITAN EX

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022661310 Catalog Number :

Device Description : TITAN-E 20K MOTOR (SWIVEL)

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

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