# K990060: MACH 7

- Pathway: 510(k) (Traditional)
- Applicant: Kreativ, Inc.
- Decided: Jun 15, 2000 after 524 days
- Product code: KOJ (Airbrush)
- Device class: 2
- Regulation: 21 CFR 872.6080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K921748 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921748: Model 2000 Dental Air Abrasive System, Texas Airsonics, Inc. (1992) Summary page 1.
- K932997: Microprep Cavity Preperation System, Sunrise Technologies, Inc. (1994) Summary page 1.
- K980216: Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6, Kreativ, Inc. (1998) Summary page 1.

## Indications for use
The Kreativ Mach 7 Air Abrasion system is used for cavity preparation in Classes [, I, HI, IV, and V. The uses include removal of tooth structure and restorative dental materials, and site preparation for pit and fissure sealant therapy and bonding of porcelain and ceramic. It may also be used for restoration prophylaxis.

Source page: https://510kreport.com/device/K990060
Methodology: https://510kreport.com/methodology