Deguprint

FDA 510(k) K955465 · Degussa Corp.

Substantially Equivalent

510(k) numberK955465

Submission

Device name
Deguprint
Applicant
Degussa Corp.
South Plainfield, NJ, US
Received
November 30, 1995
Decision date
December 28, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
ELW – Material, Impression
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3660
Specialty
Dental

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Questions and answers

When was Deguprint cleared by the FDA?

Deguprint (K955465) received a 510(k) decision of Substantially Equivalent on December 28, 1995, 28 days after the submission was received.

What is the product code of K955465?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.