Duralastic Anatomical Nasal Implants

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

510(k) Number

K971481 ↗

FDA Product Code

FZE

Device Class

Class II

Regulation

21 CFR Part 878.3680

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 types of nasal structures can the Duralastic Anatomical Nasal Implants be used to augment or reconstruct, and how are they shaped to match anatomy?

  The Duralastic Anatomical Nasal Implants are designed to augment or reconstruct nasal structures by providing support to areas from the alar cartilage (the base of the nose) up to the radix (the bridge near the forehead). They come in two primary configurations: an ‘L’-shaped design and a straight shape, both featuring a concave-convex dorsal aspect to better conform to the natural curvature of the nasal bridge. This anatomical shaping helps ensure a more natural appearance and functional support during plastic surgery procedures.

• Are the Duralastic Anatomical Nasal Implants reusable, or are they intended for single-use only? How does this affect their handling and storage?

  The Duralastic Anatomical Nasal Implants are classified as single-use devices, meaning they are intended for one-time use in a surgical setting. This classification ensures sterility is maintained for each procedure, reducing the risk of infection. As a result, they must be stored in their original sterile packaging until use and cannot be reused or reprocessed after opening.

• How do I determine the correct size or variant of the Duralastic Anatomical Nasal Implant for a patient’s specific anatomical needs?

  The Duralastic Anatomical Nasal Implants come in multiple sizes and variants, each identified by unique reference codes (e.g., 1032347, 3002807693). These variants are designed to accommodate different anatomical requirements, ensuring compatibility with the patient’s nasal structure. Your selection should be based on pre-surgical measurements and consultation with the manufacturer’s sizing guidelines to match the patient’s specific needs.

• What regulatory pathway does the Duralastic Anatomical Nasal Implant follow, and how does this affect its use in clinical settings?

  The Duralastic Anatomical Nasal Implants are regulated under the FDA’s 510(k) clearance process (K971481) and are classified as Class II devices with special controls. This means they have undergone a review by the FDA to demonstrate substantial equivalence to a predicate device, ensuring they meet safety and effectiveness standards. Clinicians can rely on this regulatory clearance when incorporating the implants into plastic surgery procedures, as it confirms their compliance with FDA requirements.

• How should the sterile packaging of the Duralastic Anatomical Nasal Implants be handled to maintain sterility before use?

  Since the implants are supplied sterile, it’s critical to handle their packaging carefully to preserve sterility. The packaging should remain unopened until immediately before use, and the sterile field should be maintained throughout the surgical procedure. Avoid touching the implant itself or its immediate surroundings with unsterile hands or instruments, and follow standard sterile technique protocols to prevent contamination.