Sealapex 4

• • Terminated Z-2836-2016 FDA Class II ·initiated 31 Aug 2016

  SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11.

510(k) Number

K010940 ↗

FDA Product Code

KIF

Device Class

Class II

Regulation

21 CFR Part 872.3820

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Prodigy 4

  Class II

  FDA 510(k) K990898 Active Cleared 6 Apr 1999

• Kerr Gel Etchant

  Class II

  FDA 510(k) K000954 Active Cleared 28 Apr 2000

• Point 4 Flowable

  Class II

  FDA 510(k) K012321 Active Cleared 27 Aug 2001

• Temp-Bond Ne 2

  Class II

  FDA 510(k) K003658 Active Cleared 4 Jan 2001

• Extrude

  Class II

  FDA 510(k) K940379 Active Cleared 22 Mar 1994

• Optibond Solo Plus

  Class II

  FDA 510(k) K990498 Active Cleared 8 Mar 1999

See all devices from Sybron Dental Specialties, Inc. →

• What is the Sealapex 4 used for in endodontic treatment?

  The Sealapex 4 is a resin-based root canal filling material designed specifically to seal microscopic gaps between the root canal filling material and the dentinal walls. This hermetic seal prevents microbial leakage, reducing the risk of infection and supporting long-term periradicular healing during endodontic therapy.

• How is the Sealapex 4 supplied, and what are its sterility and reuse requirements?

  The Sealapex 4 is supplied as a single-use, non-sterile kit intended exclusively for dental office use. Since it is non-sterile, the user must sterilize the product prior to application. It is not designed for reuse, adhering to standard single-use medical device practices.

• Does the Sealapex 4 require any special handling or storage conditions?

  The Sealapex 4 is non-sterile and must be sterilized by the user before use. While specific storage conditions are not detailed in the provided data, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity until sterilization and application.

• Is the Sealapex 4 compatible with MRI procedures?

  The provided data does not mention MRI compatibility for the Sealapex 4. Clinicians should verify compatibility with their specific MRI equipment and protocols before use, as resin-based materials may not be universally safe in all MRI environments.

• What regulatory pathway was followed for the FDA clearance of the Sealapex 4?

  The Sealapex 4 was cleared through the FDA’s Traditional 510(k) pathway, which demonstrates that it is substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with FDA regulations for Class II medical devices under the product code KIF, intended exclusively for dental specialty applications.