# K974649: Bio-Post Dental Post System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Aeromedical, Inc.
- Decided: May 1, 1998 after 140 days
- Product code: ELR (Post, Root Canal)
- Device class: 1
- Regulation: 21 CFR 872.3810
- 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) austenitic alloy root canal posts legally marketed by Essential Dental Systems: named in the summary without a submission number

## Indications for use
The Bio-Post is a dental root canal post intended to be cemented into the root canal of a tooth to stabilized and support a restoration.

Source page: https://510kreport.com/device/K974649
Methodology: https://510kreport.com/methodology