# K983183: Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P

- Pathway: 510(k) (Traditional)
- Applicant: Bien Air USA, Inc.
- Decided: Dec 10, 1998 after 90 days
- Product code: EFB (Handpiece, Air-Powered, Dental)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031145: Estylus Electric Motor System (2003), 10 descendants of its own
- K072989: Axis System (2008), 8 descendants of its own
- K143704: Advanced Air System (2015), 7 descendants of its own
- K083101: Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight Nosecones (2009), 7 descendants of its own
- K162926: Air-Powered Handpieces and Handpiece Attachments (2017), 6 descendants of its own

Source page: https://510kreport.com/device/K983183
Methodology: https://510kreport.com/methodology