# K082249: Morpheus

- Pathway: 510(k) (Abbreviated)
- Applicant: Meibach Tech Ltda
- Decided: Dec 31, 2009 after 510 days
- Product code: EJI (Syringe, Cartridge)
- Device class: 2
- Regulation: 21 CFR 872.6770
- 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
MORPHEUS is an instrument intended solely to be used for anesthetic applications inside the oral region in human beings by dentistry professionals certified by local laws.

Source page: https://510kreport.com/device/K082249
Methodology: https://510kreport.com/methodology