Prepair

FDA 510(k) K033215 · Danville Materials, Inc.

Substantially Equivalent

510(k) numberK033215

Submission

Device name
Prepair
Applicant
Danville Materials, Inc.
San Ramon, CA, US
Received
October 3, 2003
Decision date
January 9, 2004
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KOJ – Airbrush
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6080
Specialty
Dental

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Questions and answers

When was Prepair cleared by the FDA?

Prepair (K033215) received a 510(k) decision of Substantially Equivalent on January 9, 2004, 98 days after the submission was received.

What is the product code of K033215?

The FDA product code is KOJ – Airbrush, a Class II (moderate risk) device regulated under 21 CFR 872.6080.