# K133088: ZX-27

- Pathway: 510(k) (Traditional)
- Applicant: M&M Dental Studio, Inc.
- Decided: Jan 2, 2015 after 459 days
- Product code: EJX (Anchor, Preformed)
- Device class: 1
- Regulation: 21 CFR 872.3130
- 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
ZX-27 is a preformed anchor, designed to be incorporated into a dental appliance, such as a denture, to help stabilize the appliance in the patient’s mouth.

Source page: https://510kreport.com/device/K133088
Methodology: https://510kreport.com/methodology