# K980543: Denoptix Barrier Envelope  (Size 0-4)

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Apr 14, 1998 after 61 days
- Product code: EHD (Unit, X-Ray, Extraoral With Timer)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884827 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884827: Kodak Dental Barrier Pac, Eastman Kodak Company (1989) Summary page 1.

## Indications for use
The DenOptix Barrier Envelope is a single-use device intended for use with the DenOptix Digital Imaging System (K955643) to prevent contamination of the phosphor imaging plate with saliva and other bodily fluids.

Source page: https://510kreport.com/device/K980543
Methodology: https://510kreport.com/methodology