# K130421: Meron Application Capsules

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Aug 14, 2013 after 175 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- 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
Luting of metal-based crowns, bridges, inlays and onlays Luting of high-strength all-ceramic crowns and bridges (such as aluminum oxide. lithium di silicate and zirconium oxide ceramics) Luting of metal-based and high-strength all-ceramic crowns and bridges (such as aluminum oxide, lithium disilicate and zirconium oxide ceramics) on implant abutments Luting of metal root posts or indirect metal post core build-ups Luting of prefabricated steel crowns Luting of orthodontic bands

Source page: https://510kreport.com/device/K130421
Methodology: https://510kreport.com/methodology