Sybron/Kerr Contour

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

510(k) Number

K820181 ↗

FDA Product Code

EJJ

Device Class

Class II

Regulation

21 CFR Part 872.3070

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K792060 Active Cleared 4 Dec 1979

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  Class II

  FDA 510(k) K854855 Active Cleared 30 Jan 1986

• Unilab Culturing Set

  Class II

  FDA 510(k) K792648 Active Cleared 6 Feb 1980

• Castle Steam Sterilization Indicator

  Class II

  FDA 510(k) K810614 Active Cleared 24 Jun 1981

• Digital Injector Sys

  Class II

  FDA 510(k) K833138 Active Cleared 14 Nov 1983

• Coreform Molds

  Class I

  FDA 510(k) K801530 Active Cleared 28 Jul 1980

See all devices from Sybron Corp. →

• What types of dental restorations is the Sybron/Kerr Contour specifically designed for, and how does it differ from other dental alloys or amalgams?

  The Sybron/Kerr Contour is formulated for both direct and indirect dental restorations, meaning it can be used to fill cavities in situ (direct) or fabricated in a lab before placement (indirect). Unlike some modern alternatives, it is an amalgam alloy, which historically offers high durability and structural support for posterior teeth (molars and premolars) where strength is critical. Its design emphasizes long-term functionality and biocompatibility within the oral environment, making it suitable for patients requiring reliable, long-lasting restorations.

• Is the Sybron/Kerr Contour intended for reuse, or is it meant for single-use in clinical settings?

  The Sybron/Kerr Contour is explicitly supplied for single-use applications in clinical settings. This aligns with standard practices for dental restorative materials, where each application involves mixing or preparing the alloy for a specific patient’s restoration. Reuse is not recommended or supported by the manufacturer’s documentation, as it could compromise sterility or performance.

• What regulatory pathway did the Sybron/Kerr Contour follow to gain market authorization, and what does this mean for clinicians?

  The Sybron/Kerr Contour received FDA clearance via a Traditional 510(k) pathway (K820181), which means it was deemed substantially equivalent to a legally marketed predicate device at the time of submission (1982). Clinicians should note that this classification (Class II) indicates it is subject to general controls and special controls for dental restorative materials, ensuring compliance with safety and effectiveness standards. The product is regulated under FDA product code EJJ and regulation 872.3070, which governs dental alloys and amalgams.

• Are there specific storage instructions provided for the Sybron/Kerr Contour, and what should clinicians consider when handling it?

  The provided data does not include explicit storage conditions for the Sybron/Kerr Contour. However, as a dental restorative material, it should generally be stored in a cool, dry place away from direct sunlight or extreme temperatures to maintain its integrity. Clinicians should also ensure the packaging remains uncompromised until use, as the material is intended for single-use. Proper handling and storage are critical to preserving the alloy’s properties for optimal performance during restorative procedures.