# K151149: Ready-Fit

- Pathway: 510(k) (Traditional)
- Applicant: Den Tek Oral Care, Inc.
- Decided: Sep 30, 2015 after 153 days
- Product code: OBR (Mouthguard, Over-The-Counter)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K022809 (2003). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082301: Grind NO More, Placontrol, Inc. (2008) Summary page 4.

## Most influential descendants
- K222424: Protect-It Custom Fit Dental Guard (2022), 0 descendants of its own
- K202974: DenTek Fresh Protect Dental Guard (2020), 0 descendants of its own

## Indications for use
Ready-Fit Disposable Dental Guard is indicated for protection for nighttime teeth grinding or bruxism. It is intended to reduce damage to teeth by cushioning them and keeping them apart during grinding.

Source page: https://510kreport.com/device/K151149
Methodology: https://510kreport.com/methodology