STV Pro 2

FDA 510(k) K033419 · Trophy Radiologie

Substantially Equivalent

510(k) numberK033419

Submission

Device name
STV Pro 2
Applicant
Trophy Radiologie
Marne La Vallee Cedex 2, FR
Received
October 27, 2003
Decision date
February 2, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EIA – Unit, Operative Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.6640
Specialty
Dental

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Questions and answers

When was STV Pro 2 cleared by the FDA?

STV Pro 2 (K033419) received a 510(k) decision of Substantially Equivalent on February 2, 2004, 98 days after the submission was received.

What is the product code of K033419?

The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.