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

Explorer, Operative (EKB) (6) Spreader, Pulp Canal Filling Material, Endodontic (EKK) (4)

Premarket Exempt

Yes No

Clear

StarDental Instrument Solutions - D7022021480 Catalog Number :

Device Description : INSTR MG DE EXPLORER 3

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022021540 Catalog Number :

Device Description : INSTR MG DE EXPLORER 5

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022021670 Catalog Number :

Device Description : INSTR MG DE EXPLORER 6-23

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022021700 Catalog Number :

Device Description : INSTR MG DE EXPL DG 16

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022021710 Catalog Number :

Device Description : INSTR MG DE EXPL 16-17

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022021720 Catalog Number :

Device Description : INSTR MG DE EXPL DG16-23

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKB

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022023970 Catalog Number :

Device Description : INSTR MG SE SPREADER 3

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022024020 Catalog Number :

Device Description : INSTR MG SE SPREADER D11

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022024030 Catalog Number :

Device Description : INSTR MG SE SPREADER D11T

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022024050 Catalog Number :

Device Description : INSTR MG SE SPREADER MA57

Device Class : 1

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : EKK

Prescription Use : Yes

Device Count : 1

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