DELSONIC 2000

Scaler, Ultrasonic

DELDENT LTD.

The following data is part of a premarket notification filed by Deldent Ltd. with the FDA for Delsonic 2000.

Pre-market Notification Details

Device IDK014238
510k NumberK014238
Device Name:DELSONIC 2000
ClassificationScaler, Ultrasonic
Applicant DELDENT LTD. 19 KEREN KAYEMET ST. Petach Tikvah,  IL 49372
ContactAlan Edel
CorrespondentAlan Edel
DELDENT LTD. 19 KEREN KAYEMET ST. Petach Tikvah,  IL 49372
Product CodeELC  
CFR Regulation Number872.4850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-26
Decision Date2002-01-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290016281941 K014238 000
07290016281934 K014238 000
07290016281927 K014238 000
07290016281910 K014238 000
07290016281903 K014238 000

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