Duralastic I and Duralastic II

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K971480 ↗

FDA Product Code

MIB

Device Class

Class II

Regulation

21 CFR Part 874.3620

Advisory Committee

Ear, Nose, Throat

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 are Duralastic I and II used for?

  These silicone elastomer blocks are intended for short-term nasal splinting, wound dressings, and wound covering for gastroschisis. They are also used as suture bolsters, drains, scar coverings, and for temporary facilitation of osteogenesis and guided tissue regeneration between teeth.

• Is the Duralastic I or II reusable?

  No, the device is supplied as a sterile, single-use product and is not reusable. It is intended for use in medical settings and should be discarded after one use.

• How should the Duralastic I or II be stored?

  The device should be stored in a dry environment until use. It is not MRI safe.

• What is the regulatory status of the Duralastic I and II?

  The device is regulated under FDA 510(k) clearance. It has a decision of Substantially Equivalent and was reviewed by the Ear, Nose, and Throat advisory committee.