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) (6) Handpiece, Air-Powered, Dental (EFB) (3) Scaler, Ultrasonic (ELC) (1)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022634850 Catalog Number :

Device Description : SENSITIP KIT

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022637580 Catalog Number :

Device Description : HIFLO 4-LINE FO SWIVEL

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022637720 Catalog Number :

Device Description : HiFlo 6-Pin Swivel, 3.3 Volts

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022637730 Catalog Number :

Device Description : HiFlo 6-Pin Swivel, 3.1 Volts

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022638910 Catalog Number :

Device Description : RPM 5K LOWSPEED

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022638920 Catalog Number :

Device Description : RPM 20K LOW SPEED

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022638930 Catalog Number :

Device Description : RPM TORQUE MULTIPLIER

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022638940 Catalog Number :

Device Description : RPM STRAIGHT NOSECONE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022638950 Catalog Number :

Device Description : RPM BB MTA

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022638970 Catalog Number :

Device Description : RPM BB MANUAL LATCH ANGLE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

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