# K971479: Duralastic Anatomical Malar Implants

- Pathway: 510(k) (Traditional)
- Applicant: Allied Biomedical Corp.
- Decided: Jul 18, 1997 after 86 days
- Product code: LZK (Implant, Malar)
- Device class: 2
- Regulation: 21 CFR 878.3550
- 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 K952707 (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)
- K952707: Silicone Elastomer Malar Implant, Spirit Ridge Technologies (1995) Summary page 1.

## Indications for use
The Duralastic Anatomical Chin Implants are intended to be used to augment or reconstruct the maxilla for cosmetic or reconstructive surgery.

Source page: https://510kreport.com/device/K971479
Methodology: https://510kreport.com/methodology