Degulor a

FDA 510(k) K951786 · Degussa Corp.

Substantially Equivalent

510(k) numberK951786

Submission

Device name
Degulor a
Applicant
Degussa Corp.
South Plainfield, NJ, US
Received
April 17, 1995
Decision date
June 12, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EJT – Alloy, Gold-Based Noble Metal
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3060
Specialty
Dental

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Questions and answers

When was Degulor a cleared by the FDA?

Degulor a (K951786) received a 510(k) decision of Substantially Equivalent on June 12, 1995, 56 days after the submission was received.

What is the product code of K951786?

The FDA product code is EJT – Alloy, Gold-Based Noble Metal, a Class II (moderate risk) device regulated under 21 CFR 872.3060.