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) Scaler, Ultrasonic (ELC) (4) Handpiece, Air-Powered, Dental (EFB) (1)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022639700 Catalog Number :

Device Description : TITAN-T BB MOTOR TO ANGLE ADAPTOR

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022639720 Catalog Number :

Device Description : RESTORATIVE KIT TITAN 3 20K 4 LINE, S.S.

Device Class :

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022639960 Catalog Number :

Device Description : Deziree's Hygiene Solution

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EFB, ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022640730 Catalog Number :

Device Description : TITAN 3 BB MOTOR TO ANGLE ADAPTOR

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022641460 Catalog Number :

Device Description : TITAN LF BB AUTOLATCH ANGLE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022641490 Catalog Number :

Device Description : TITAN BB FG AUTOCHUCK

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022641510 Catalog Number :

Device Description : TITAN LF BB FG AUTOCHUCK

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022641520 Catalog Number :

Device Description : UNIVERSAL TIP - 100/BAG

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022641660 Catalog Number :

Device Description : SICKLE SCALER TIP - 100/BAG

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022641690 Catalog Number :

Device Description : PERIO SCALER TIP - 100/BAG

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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