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) (8) Scaler, Ultrasonic (ELC) (2)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022624090 Catalog Number :

Device Description : TITAN 3 5K FIXED BACKEND

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022624100 Catalog Number :

Device Description : TITAN 3 20K FIXED BACKEND

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : No

Device Count : 1

StarDental Instrument Solutions - D7022625700 Catalog Number :

Device Description : TITAN ENDO ANGLE, A/L

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022625710 Catalog Number :

Device Description : ^TITAN ENDO ANGLE, M/L

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022625830 Catalog Number :

Device Description : ^RESTORATIVE KIT TITAN 3, 20K SWL, S.S.

Device Class :

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022627380 Catalog Number :

Device Description : TITAN 3 LF BB MANUAL LATCH ANGLE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022627400 Catalog Number :

Device Description : TITAN 3 LF BB M/C FG ANGLE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022632300 Catalog Number :

Device Description : TITAN 16:1 ENDODONTIC 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 - D7022633970 Catalog Number :

Device Description : TITAN SCALER TIP, LEFT PERIO

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022633980 Catalog Number :

Device Description : Titan Scaler Tip - Right Perio

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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