# K080458: Mis Crest Widener

- Pathway: 510(k) (Traditional)
- Applicant: Mis - Implant Technologies, Ltd.
- Decided: Dec 17, 2008 after 301 days
- Product code: MQN (External Mandibular Fixator And/Or Distractor)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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 K002152 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043555: Synthes 9USA) Alveolar Ridge Distractor, Synthes (Usa) (2005) Summary page 2.
- K002152: Track 1.0 & 1.5 MM Systems-Tissue Regeneration by Alveolar Callus Distraction, KLS-Martin L.P. (2000) Summary page 2.
- K042278: Oral Osteodistraction Rod Appliance (Rod 5), Oral Osteodistraction, L.P. (2005) Summary page 2.

## Indications for use
The MIS Crest Widener is intended to: Preparing the narrow alveolar crest for implantation as an alternative to bone augmentation. The device is used temporary and is removed after the treatment has been completed. The device is for single use only.

Source page: https://510kreport.com/device/K080458
Methodology: https://510kreport.com/methodology