Eugenone

FDA 510(k) K051952 · Scientific Pharmaceuticals, Inc.

Substantially Equivalent

510(k) numberK051952

Submission

Device name
Eugenone
Applicant
Scientific Pharmaceuticals, Inc.
Pomona, CA, US
Received
July 18, 2005
Decision date
September 7, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EMA – Cement, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3275
Specialty
Dental

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Questions and answers

When was Eugenone cleared by the FDA?

Eugenone (K051952) received a 510(k) decision of Substantially Equivalent on September 7, 2005, 51 days after the submission was received.

What is the product code of K051952?

The FDA product code is EMA – Cement, Dental, a Class II (moderate risk) device regulated under 21 CFR 872.3275.