# K141027: 3D Eptfe; Anatomical Chin, Curvilinear Chin, Extended Anatomical Chin Implant, Submalar II Implant, Dorsal Columella Imp

- Pathway: 510(k) (Traditional)
- Applicant: Implantech Associates, Inc.
- Decided: Jul 10, 2014 after 79 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K172389: ePTFE-Coated Auricular Implant (2018), 0 descendants of its own

## Indications for use
The Implantech ePTFE Facial Implants are intended for implantation to augment or reconstruct underdeveloped areas of the face. The devices are available in various Chin, nasal, malar and carving block three dimensional shapes all which may be additionally carved to allow the surgeon to further shape the device should additional shaping be desired.

Source page: https://510kreport.com/device/K141027
Methodology: https://510kreport.com/methodology