Sandblaster

FDA 510(k) K931845 · Mirage Dental Systems

Substantially Equivalent

510(k) numberK931845

Submission

Device name
Sandblaster
Applicant
Mirage Dental Systems
Kansas City, KS, US
Received
April 13, 1993
Decision date
March 1, 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
KOJ – Airbrush
Device class
Class II (moderate risk)
Regulation
21 CFR 872.6080
Specialty
Dental

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Questions and answers

When was Sandblaster cleared by the FDA?

Sandblaster (K931845) received a 510(k) decision of Substantially Equivalent on March 1, 1995, 687 days after the submission was received.

What is the product code of K931845?

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