# K021383: Zeodyne Toothbrush with Agion Antimicrobial

- Pathway: 510(k) (Traditional)
- Applicant: Agion Technologies, LLC
- Decided: Jul 17, 2002 after 76 days
- Product code: EFW (Toothbrush, Manual)
- Device class: 1
- Regulation: 21 CFR 872.6855
- 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) Crest Toothbrush with MicroShield: named in the summary without a submission number
- (no number) Disposable Stethoscope Diaphragm with AgION Antimicrobial Compound: named in the summary without a submission number

## Indications for use
The Zeodyne Toothbrush with AgION'rM Antimicrobial is intended to remove adberent plaque and, food debris from the teeth. The addition of the antimicrobial agent is to prevent the growth of bacteria on the toothbrush between brushings. The antimicrobial treatment is not intended to have m y effect on the user.

Source page: https://510kreport.com/device/K021383
Methodology: https://510kreport.com/methodology