Duralastic Anatomical Chin Implants

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K971478 ↗

FDA Product Code

FWP

Device Class

Class II

Regulation

21 CFR Part 878.3550

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Duralastic II

  Class II

  FDA 510(k) K955370 Active Cleared 8 Feb 1996

• Duralastic I

  Class II

  FDA 510(k) K955368 Active Cleared 8 Feb 1996

• Duralastic Anatomical Malar Implants

  Class II

  FDA 510(k) K971479 Active Cleared 18 Jul 1997

• Kelocate Sheeting

  Class I

  FDA 510(k) K982051 Active Cleared 5 Aug 1998

• Duralastic Silicone Tubing

  Class I

  FDA 510(k) K955433 Active Cleared 26 Jan 1996

• Kelocote

  Class I

  FDA 510(k) K954413 Active Cleared 29 Nov 1995

See all devices from Allied Biomedical Corp. →

• What is the primary purpose of the Duralastic Anatomical Chin Implants?

  The Duralastic Anatomical Chin Implants are designed to restore or enhance facial contours by providing structural support beneath the skin and muscle layers of the chin region. They are intended for use in general plastic surgery procedures to achieve aesthetic improvement through surgical placement.

• Are these implants reusable, and how should they be handled?

  Yes, the Duralastic Anatomical Chin Implants are reusable for surgical purposes. When used in sterile settings, they must be handled according to sterile techniques to ensure patient safety and device integrity.

• What configurations are available for these implants?

  These implants are supplied in both sterile and non-sterile configurations, as indicated by the FDA 510(k) clearance under regulation 21 CFR 878.3550. The choice between sterile and non-sterile depends on the clinical setting and procedure requirements.

• How are these implants regulated and cleared by the FDA?

  The Duralastic Anatomical Chin Implants are classified under Class II special controls and were cleared by the FDA on July 18, 1997, following a review by the General Plastic Surgery Advisory Committee (SU). The clearance was based on a determination of substantial equivalence to a predicate device.

• What types of procedures are these implants intended for?

  These implants are specifically intended for use in general plastic surgery procedures aimed at augmenting the chin region. They are designed to conform anatomically, ensuring a natural appearance while providing structural support for improved facial contours.