# K971478: Duralastic Anatomical Chin Implants

- Pathway: 510(k) (Traditional)
- Applicant: Allied Biomedical Corp.
- Decided: Jul 18, 1997 after 86 days
- Product code: FWP (Prosthesis, Chin, Internal)
- 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. Our reading found no predicate number; beside “510(k)” the summary reads “K952708”, which our checks could not confirm as its predicate.
- (no number) Applied Biomedical chin implants: named in the summary without a submission number

## Most influential descendants
- K973575: Duralastic Anatomical Chin Implants (1997), 1 descendant of its own
- K090803: Hanson Medical Facial Implants (2010), 0 descendants of its own

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

Source page: https://510kreport.com/device/K971478
Methodology: https://510kreport.com/methodology