# K063554: Meron Plus

- Pathway: 510(k) (Abbreviated)
- Applicant: Voco GmbH
- Decided: Jan 12, 2007 after 46 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
Longest line of descent: 1 generation back to K946100 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K946100: Fuji Duet, GC America, Inc. (1995) Summary page 1.

## Indications for use
Meron Plus is intended for permanent cementation of porcelain-fused-to metal crowns, bridges on hard dental tissue and cores rebuilt with amalgam, composite or glass ionomer cements. Meron Plus is further intended for the permanent cementation of metal inlays, onlays, crowns and bridges, posts, crowns manufactured from alumina-only or zirkonia-only cores and orthodontic appliances.

Source page: https://510kreport.com/device/K063554
Methodology: https://510kreport.com/methodology