SSS, Model 1072001 (Standard 4-HOLE Model) & 1072002 (Standard 2-HOLE Model)

FDA 510(k) K032995 · Micron Corp.

Substantially Equivalent

510(k) numberK032995

Submission

Device name
SSS, Model 1072001 (Standard 4-HOLE Model) & 1072002 (Standard 2-HOLE Model)
Applicant
Micron Corp.
Ota-Ku, Tokyo, JP
Received
September 25, 2003
Decision date
November 20, 2003
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary 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 SSS, Model 1072001 (Standard 4-HOLE Model) & 1072002 (Standard 2-HOLE Model) cleared by the FDA?

SSS, Model 1072001 (Standard 4-HOLE Model) & 1072002 (Standard 2-HOLE Model) (K032995) received a 510(k) decision of Substantially Equivalent on November 20, 2003, 56 days after the submission was received.

What is the product code of K032995?

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