Deldent Ultrasonic Inserts

FDA 510(k) K011179 · Deldent , Ltd.

Substantially Equivalent

510(k) numberK011179

Submission

Device name
Deldent Ultrasonic Inserts
Applicant
Deldent , Ltd.
Petach Tikvah, IL
Received
April 17, 2001
Decision date
June 5, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ELC – Scaler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4850
Specialty
Dental

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Questions and answers

When was Deldent Ultrasonic Inserts cleared by the FDA?

Deldent Ultrasonic Inserts (K011179) received a 510(k) decision of Substantially Equivalent on June 5, 2001, 49 days after the submission was received.

What is the product code of K011179?

The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.