Magnacore

FDA 510(k) K930584 · Scientific Pharmaceuticals, Inc.

Substantially Equivalent

510(k) numberK930584

Submission

Device name
Magnacore
Applicant
Scientific Pharmaceuticals, Inc.
Skokie, IL, US
Received
February 4, 1993
Decision date
February 22, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EBF – Material, Tooth Shade, Resin
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3690
Specialty
Dental

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Questions and answers

When was Magnacore cleared by the FDA?

Magnacore (K930584) received a 510(k) decision of Substantially Equivalent on February 22, 1994, 383 days after the submission was received.

What is the product code of K930584?

The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.