# K083479: Biocryl X

- Pathway: 510(k) (Traditional)
- Applicant: Great Lakes Orthodontics, Ltd.
- Decided: Feb 27, 2009 after 95 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- 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) Biocrylrm: named in the summary without a submission number

## Indications for use
Biocryl X is indicated for the fabrication of dental radiographic templates worn during x-ray imaging.

Source page: https://510kreport.com/device/K083479
Methodology: https://510kreport.com/methodology