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

Instrument, Diamond, Dental (DZP) (8) Handpiece, Direct Drive, Ac-Powered (EKX) (2)

Premarket Exempt

No Yes

Clear

StarDental Instrument Solutions - D7020659900 Catalog Number :

Device Description : ISTAR PROPHY CHARGE STAND

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7020659910 Catalog Number :

Device Description : ISTAR PROPHY HANDPIECE

Device Class : 1

Duns Number: 059010363

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

StarDental Instrument Solutions - D7022001690 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 103SP

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

StarDental Instrument Solutions - D7022001740 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 110P

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

StarDental Instrument Solutions - D7022002520 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 556-4P

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

StarDental Instrument Solutions - D7022002720 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 557-7P

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

StarDental Instrument Solutions - D7022002760 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 558-7P

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

StarDental Instrument Solutions - D7022002880 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 699-9P

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

StarDental Instrument Solutions - D7022002950 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 699-11P

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

StarDental Instrument Solutions - D7022003030 Catalog Number :

Device Description : CLASSIQUE DIA INSTRUMENTS 700-8P

Device Class :

Duns Number: 059010363

Premarket Exempt : Yes

Product Code : DZP

Prescription Use : Yes

Device Count : 5

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