# K935440: Johnson & Johnson Fluoride Dental Floss, Mint Waxed

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Consumer Products, Inc.
- Decided: Feb 3, 1994 after 83 days
- Product code: JES (Floss, Dental)
- Device class: 1
- Regulation: 21 CFR 872.6390
- 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 K925409 (1993). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925409: Oral-B Dental Floss with Fluoride, Oral-B Laboratories (1993) Summary page 1.
- (no number) JOHNSON & JOHNSON Dental Floss, Mint Waxed: named in the summary without a submission number

## Most influential descendants
- K952091: Vutler G.U.M. with Fluoride (1995), 1 descendant of its own
- K130186: Dentek Easy Brush with Fluoride (2013), 0 descendants of its own
- K102053: Butler Calci-Flor Prophylaxis Paste (2011), 0 descendants of its own

## Indications for use
However, the primary mode of action of JOHNSON & JOHNSON Fluoride Dental Floss, Mint Waxed is to mechanically remove plaque and food particles from between the teeth, and along and under the gumline.

Source page: https://510kreport.com/device/K935440
Methodology: https://510kreport.com/methodology