Bisco Composite

FDA 510(k) K940030 · Bisco, Inc.

Substantially Equivalent

510(k) numberK940030

Submission

Device name
Bisco Composite
Applicant
Bisco, Inc.
Itasca, IL, US
Received
January 3, 1994
Decision date
February 4, 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
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 Bisco Composite cleared by the FDA?

Bisco Composite (K940030) received a 510(k) decision of Substantially Equivalent on February 4, 1994, 32 days after the submission was received.

What is the product code of K940030?

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