# K134008: MD-Flex Heavy Body

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed, Inc.
- Decided: Apr 9, 2014 after 100 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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 K943574 (1994). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040053: Precision VPS Impression Material, Discus Dental, Inc. (2004) Summary page 1.
- K101617: Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge Refill, Heraeus Kulzer, LLC (2010) Summary page 1.

## Indications for use
MVD-flex Heavy Body is used to record the shape of the patients teeth and alveolar ridges.

Source page: https://510kreport.com/device/K134008
Methodology: https://510kreport.com/methodology