# K972446: Pedo Cush Pedo Cuddle

- Pathway: 510(k) (Traditional)
- Applicant: Cavity Free Kids, Inc.
- Decided: Nov 13, 1997 after 136 days
- Product code: FMQ (Restraint, Protective)
- Device class: 1
- Regulation: 21 CFR 880.6760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Olympic Papoose Board: named in the summary without a submission number

## Indications for use
Pedo Cush Pedo Cuddie is to be used under the direction and/or the supervision of a dentist only, as a tool to help manage an uncontrollable child for the purposc of protection of the child from injury while receiving dental treatment. It is not to be used as a punishment tool. The Health Professional must be in control of his/hers emotions while using the Pedo Cush if at any time he/she foels the overwhelming of the emotions — he/she must take a break, deliver the child back to the parent’s amms. After the emotions are under control then he/she may continue to work. Remember that the option of referring out to another dentist is a possibility.

Source page: https://510kreport.com/device/K972446
Methodology: https://510kreport.com/methodology