# K134015: M-PM-Disc

- Pathway: 510(k) (Traditional)
- Applicant: Merz Dental GmbH
- Decided: Apr 11, 2014 after 105 days
- Product code: MQC (Mouthguard, Prescription)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K780619 (1978). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062828: Mouthguard and Aligner Materials, Dentsply Intl., Inc. (2006) Summary page 1.
- K030588: Artegral and Polystar Selection, Merz Dental GmbH (2003) Summary page 1.
- K071548: Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored, Merz Dental GmbH (2007) Summary page 1.

## Most influential descendants
- K191836: Ceramill A-Splint (2019), 0 descendants of its own

## Indications for use
The Menz Dental GmbH M-PM-Disc (Clear) is indicated for the fabrication of removable bite splints such as mouthguard and nightguards.

Source page: https://510kreport.com/device/K134015
Methodology: https://510kreport.com/methodology