# K222424: Protect-It Custom Fit Dental Guard

- Pathway: 510(k) (Traditional)
- Applicant: Doc Brands, Inc.
- Decided: Oct 7, 2022 after 57 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: 4 generations back to K022809 (2003). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151149: Ready-Fit, Den Tek Oral Care, Inc. (2015) Summary page 4.

## Indications for use
Protect-It Custom Fit Dental Guard is indicated for protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to teeth associated with bruxing or nighttime teeth grinding.

Source page: https://510kreport.com/device/K222424
Methodology: https://510kreport.com/methodology