# K983223: Dental Sterlization Tray/Cassette

- Pathway: 510(k) (Traditional)
- Applicant: Brasseler USA I, L.P.
- Decided: Jan 14, 1999 after 122 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device.

Source page: https://510kreport.com/device/K983223
Methodology: https://510kreport.com/methodology