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) (5) Scaler, Periodontic (EMN) (2) Cement, Dental (EMA) (1) Frame, Rubber Dam (EJE) (1) Plugger, Root Canal, Endodontic (EKR) (1)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022024190 Catalog Number :

Device Description : INSTR #1 GLICK/PLUG

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKR

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022027250 Catalog Number :

Device Description : INSTR MG DE JAQU 2Y-3Y

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022027330 Catalog Number :

Device Description : INSTR MG DE JACQ 2YS-3YS

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EMN

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022055540 Catalog Number :

Device Description : VISI-FRAME RUBBER DAM FRM

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EJE

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022063230 Catalog Number :

Device Description : RC Cement-Non Stain Kit

Device Class : 2

Duns Number: 059010363

Premarket Exempt : No

Product Code : EMA

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022575060 Catalog Number :

Device Description : TITAN 3 STRAIGHT NOSE CONE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022584430 Catalog Number :

Device Description : TITAN 3 TORQUE MULTIPLIER

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022590050 Catalog Number :

Device Description : TITAN 3 BB LATCH ANGLE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022601440 Catalog Number :

Device Description : TITAN 4-LINE SWIVEL

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022601520 Catalog Number :

Device Description : TITAN 2-LINE SWIVEL

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EGS

Prescription Use : Yes

Device Count : 1

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