# K980216: Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6

- Pathway: 510(k) (Traditional)
- Applicant: Kreativ, Inc.
- Decided: Jun 16, 1998 after 146 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: 1 generation back to K921748 (1992). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940776: Kreativ Model KV-1, Kreativ, Inc. (1994) Summary page 1.
- 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.

## Most influential descendants
- K990060: MACH 7 (2000), 0 descendants of its own
- K984415: S.S. White Technologies, Models 6500-D,6500-E, and 6500-F (1999), 0 descendants of its own

## Indications for use
The Kreativ Mach Series Air Abrasion systems are used for cavity preparation in Classes I, I, III, 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 percelain and ceramic. They are also used for restoration prophylaxis.

Source page: https://510kreport.com/device/K980216
Methodology: https://510kreport.com/methodology