# K093084: Rolence Dental High Speed Handpiece, RHP

- Pathway: 510(k) (Traditional)
- Applicant: Rolence Ent., Inc.
- Decided: Dec 16, 2009 after 76 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
Longest line of descent: 4 generations back to K935676 (1995). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062740: Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MU, Jindell Medical Instruments Co., Ltd. (2006) Summary page 1.

## Most influential descendants
- K101551: Pacemaker High-Speed Handpiece Model PM-MQ, PM-M (2010), 1 descendant of its own
- K112623: Airlight Dental Handpiece (2011), 0 descendants of its own

## Indications for use
ROLENCE Dental High Speed Handpiece, model: RHP is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

Source page: https://510kreport.com/device/K093084
Methodology: https://510kreport.com/methodology