Dentsply Professional

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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

Scaler, ultrasonic (ELC) (10)

Premarket Exempt

No Yes

Clear

Cavitron® - D003803971 Catalog Number :

Device Description : FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K FSI®-SLI®-10R

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003803981 Catalog Number :

Device Description : FOCUSED SPRAY® slimLINE® Ultrasonic Insert 25K FSI®-SLI® 3-PK

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003803991 Catalog Number :

Device Description : FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K FSI®-SLI® 3-PK

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003804001 Catalog Number :

Device Description : FOCUSED SPRAY® slimLINE® Ultrasonic Insert 25K FSI®-SLI® 2-PK

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003804011 Catalog Number :

Device Description : FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K FSI®-SLI® 2-PK

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003807941 Catalog Number :

Device Description : FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 25K FSI®-PWR-3

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003807951 Catalog Number :

Device Description : FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 25K FSI®-PWR-100

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003807961 Catalog Number :

Device Description : FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 25K FSI®-PWR-1000

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003807971 Catalog Number :

Device Description : FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K FSI®-PWR-3

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Cavitron® - D003807981 Catalog Number :

Device Description : FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K FSI®-PWR-100

Device Class : 2

Duns Number: 144140845

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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