Mach 7

FDA 510(k) K990060 · Kreativ, Inc.

Substantially Equivalent

510(k) numberK990060

Submission

Device name
Mach 7
Applicant
Kreativ, Inc.
San Diego, CA, US
Received
January 8, 1999
Decision date
June 15, 2000
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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More from Deldent , Ltd.

510(k)DeviceDecision
K983227Power BlockEIE · Traditional 12/11/1998SE
K980216Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6KOJ · Traditional 06/16/1998SE
K962376Kreativ Kuring Light SystemEBF · Traditional 03/21/1997SE
K940776Kreativ Model KV-1KOJ · Traditional 12/21/1994SE

Questions and answers

When was Mach 7 cleared by the FDA?

Mach 7 (K990060) received a 510(k) decision of Substantially Equivalent on June 15, 2000, 524 days after the submission was received.

What is the product code of K990060?

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