# K073040: SMH Flex S

- Pathway: 510(k) (Traditional)
- Applicant: Smh Biomaterial AG
- Decided: Dec 13, 2007 after 45 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K900799 (1990). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071245: Talon and Revere, Talon Acrylics, Inc. (2007) Summary page 1.
- K896130: SR-Ivocap, Ivoclar North America, Inc. (1990) Summary page 1.

## Indications for use
SMH Flex "S" is intended for the laboratory fabrication of dental prosthesis including the repair and relining of complete and/or partial dentures, occlusal splints, night guards, tooth positioners, snoring and sleep apnea devices, and other appliances as prescribed.

Source page: https://510kreport.com/device/K073040
Methodology: https://510kreport.com/methodology