# K952091: Vutler G.U.M. with Fluoride

- Pathway: 510(k) (Traditional)
- Applicant: John O. Butler Co.
- Decided: Jun 28, 1995 after 56 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: 2 generations back to K925409 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K925408: Oral-B Dental Tape with Fluoride, Oral-B Laboratories (1993) Summary page 3.
- K925409: Oral-B Dental Floss with Fluoride, Oral-B Laboratories (1993) Summary page 3.
- K935440: Johnson & Johnson Fluoride Dental Floss, Mint Waxed, Johnson & Johnson Consumer Products, Inc. (1994) Summary page 3.
- (no number) John O. Butler, Butler Weave Product: named in the summary without a submission number

## Most influential descendants
- K102053: Butler Calci-Flor Prophylaxis Paste (2011), 0 descendants of its own

## Indications for use
These products are intended to be used for the removal of adherent plaque and debris from the teeth.

Source page: https://510kreport.com/device/K952091
Methodology: https://510kreport.com/methodology