Elements Diagnostic Unit

FDA 510(k) K021298 · Sybron Endo/Analytic

Substantially Equivalent

510(k) numberK021298

Submission

Device name
Elements Diagnostic Unit
Applicant
Sybron Endo/Analytic
Orange, CA, US
Received
April 24, 2002
Decision date
June 19, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EAT – Tester, Pulp
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1720
Specialty
Dental

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Questions and answers

When was Elements Diagnostic Unit cleared by the FDA?

Elements Diagnostic Unit (K021298) received a 510(k) decision of Substantially Equivalent on June 19, 2002, 56 days after the submission was received.

What is the product code of K021298?

The FDA product code is EAT – Tester, Pulp, a Class II (moderate risk) device regulated under 21 CFR 872.1720.