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

Scaler, Ultrasonic (ELC) (4) Handpiece, Air-Powered, Dental (EFB) (3) Handpiece, Contra- And Right-Angle Attachment, Dental (EGS) (3)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022615470 Catalog Number :

Device Description : 4-LINE SWIVEL

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022615500 Catalog Number :

Device Description : 2/3-LINE SWIVEL

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022616670 Catalog Number :

Device Description : TITAN SCALER TIP - SICKLE

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022616680 Catalog Number :

Device Description : TITAN SCALER TIP- UNIVERSAL

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022616690 Catalog Number :

Device Description : TITAN SCALER TIP - PERIO

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022620520 Catalog Number :

Device Description : 430K 4-LINE HANDPIECE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022620570 Catalog Number :

Device Description : 430 SW HANDPIECE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D702262057ASPEN0 Catalog Number :

Device Description : 430SW ASPEN DENTAL HP

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022622610 Catalog Number :

Device Description : TITAN 3 5,000 MOTOR

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022622620 Catalog Number :

Device Description : TITAN 3 20,000 MOTOR

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

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