# K021417: Aart Chin Implant

- Pathway: 510(k) (Traditional)
- Applicant: Aesthetic and Reconstructive Technologies, Inc.
- Decided: Jul 2, 2002 after 60 days
- Product code: FWP (Prosthesis, Chin, Internal)
- Device class: 2
- Regulation: 21 CFR 878.3550
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Duralastic Anatomical Chin Implant: named in the summary without a submission number
- (no number) Seare Biomedical Chin Implant: named in the summary without a submission number

## Recalls of this device
- Sep 26, 2025 · Class II · Z-0946-2026: Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.

## Indications for use
The intended use for the AAR.T Chin Implant is for cosmetic augmentation and reconstruction of the chin or anterior mandibular contour. It is intended to be insated via intra-oral or submental incision.

Source page: https://510kreport.com/device/K021417
Methodology: https://510kreport.com/methodology