# K092933: Saf (Self Adjusting File)

- Pathway: 510(k) (Traditional)
- Applicant: Redent-Nova, Ltd.
- Decided: Jan 14, 2010 after 113 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: 2 generations back to K933582 (1993). 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)
- K962031: Quantec Series 2000 Endodontic Files, Tycom Dental (1996)
- K933582: Profile Series 29 Files, Tulsa Dental Products, Ltd. (1993) Summary page 2.
- (no number) ProTaper: named in the summary without a submission number

## Indications for use
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.

Source page: https://510kreport.com/device/K092933
Methodology: https://510kreport.com/methodology