# K101172: RDT3 Handpiece Head Model RDT3

- Pathway: 510(k) (Traditional)
- Applicant: Redent Nova, Ltd.
- Decided: Jul 27, 2010 after 92 days
- Product code: EFA (Handpiece, Belt And/Or Gear Driven, 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: 2 generations back to K896878 (1990). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092446: Intra Lux Head 3 Ldsy, Kaltenbach & Voigt GmbH & Co. (2009) Summary page 1.

## Indications for use
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).

Source page: https://510kreport.com/device/K101172
Methodology: https://510kreport.com/methodology