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

Airbrush (KOJ) (8) Scaler, Ultrasonic (ELC) (2)

Premarket Exempt

No Yes

Clear

Ultrasonic Scaler Insert - 07290016281552 Catalog Number : 508905

Device Description : Magnetostrictive dental scaler insert

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

Ultrasonic Scaler Insert - 07290016281569 Catalog Number : 508906

Device Description : Magnetostrictive dental scaler insert

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : ELC

Prescription Use : Yes

Device Count : 1

JETPOLISHER 2000 - 07290016281705 Catalog Number : 519200

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 - 07290016281712 Catalog Number : 519210

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 - 07290016281729 Catalog Number : 519300

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 - 07290016281736 Catalog Number : 519310

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 - 07290016281743 Catalog Number : 519500

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 - 07290016281750 Catalog Number : 519510

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 - 07290016281767 Catalog Number : 519600

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 - 07290016281774 Catalog Number : 519610

Device Description : Dental Airpolishing Unit

Device Class : 2

Duns Number: 600007124

Premarket Exempt : No

Product Code : KOJ

Prescription Use : Yes

Device Count : 1

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