DELDENT LTD.

Address:10 DOV LEVIATAN STREET,PETACH TIKVAH Central,IL

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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) (5) Airbrush (KOJ) (4) Agent, Polishing, Abrasive, Oral Cavity (EJR) (1)

Premarket Exempt

No Yes

Clear

JETPOLISHER 2000 - 07290016281781 Catalog Number : 519900

Device Description : Dental Airpolishing Unit

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

JETPOLISHER 2000 - 07290016281798 Catalog Number : 519910

Device Description : Dental Airpolishing Unit

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

JP/JST/JS HANDPIECE - 07290016281804 Catalog Number : 509111

Device Description : Dental Airpolishing Handpiece

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

JP/JST/JS HANDPIECE - 07290016281811 Catalog Number : 509120

Device Description : Dental Airpolishing Handpiece

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

JETSTREAM POWDER - 07290016281835 Catalog Number : 500004

Device Description : AIRPOLISHING POWDER. FRESH TASTING SODIUM BICARBONATE POWDER WITH MINT FLAVOR, F AIRPOLISHING POWDER. FRESH TASTING SODIUM BICARBONATE POWDER WITH MINT FLAVOR, FOR REMOVAL OF STAINS AND PLAQUE.

Device Class : 1

Duns Number: 600007124

Premarket Exempt : Yes

Product Code : EJR

Prescription Use : No

Device Count : 1

Delsonic Scaler Insert - 07290016281903 Catalog Number : 512050

Device Description : Dental scaler insert

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Delsonic Scaler Insert - 07290016281910 Catalog Number : 512051

Device Description : Dental scaler insert

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Delsonic Scaler Insert - 07290016281927 Catalog Number : 512052

Device Description : Dental scaler insert

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Delsonic Scaler Insert - 07290016281934 Catalog Number : 512053

Device Description : Dental scaler insert

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Delsonic 2000 Scaler - 07290016281941 Catalog Number : 512200

Device Description : Dental scaler unit

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

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