Austenal Dental Composite Resin

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

510(k) Number

K854957 ↗

FDA Product Code

EBD

Device Class

Class II

Regulation

21 CFR Part 872.3310

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Austenal Modified Acrylic Denture Resin

  Class II

  FDA 510(k) K853160 Active Cleared 31 Oct 1985

• White Silver Solder and Yellow Silver Solder

  Class II

  FDA 510(k) K860964 Active Cleared 26 Mar 1986

• Base, Denture, Relining, Repairing, Rebasing, Resin

  Class II

  FDA 510(k) K883799 Active Cleared 20 Oct 1988

• Vitallium Equipoise Alloy

  Class II

  FDA 510(k) K880875 Active Cleared 7 Apr 1988

• Overdenture - Stud Attachment

  Class II

  FDA 510(k) K890713 Active Cleared 14 Jul 1989

• Ncm - Alpha Alloy (Dental Bake-on Alloy)

  Class II

  FDA 510(k) K860217 Active Cleared 17 Mar 1986

See all devices from Austenal Dental, Inc. →

• What is the Austenal Dental Composite Resin used for?

  The Austenal Dental Composite Resin is designed specifically for restorative dental procedures. It serves as a durable and aesthetically pleasing filling material to repair cavities, restore tooth structure, and improve the appearance of teeth. Its formulation allows it to bond directly with natural tooth enamel, providing strength and longevity while maintaining a natural look.

• Is the Austenal Dental Composite Resin single-use or reusable?

  The Austenal Dental Composite Resin is supplied as a single-use dental material. This ensures sterility and safety in clinical settings, as it is intended for one-time use per patient to prevent cross-contamination and maintain regulatory compliance.

• What regulatory approval does the Austenal Dental Composite Resin hold?

  The Austenal Dental Composite Resin is authorized for use in the United States under FDA 510(k) clearance with the clearance number K854957. It is classified as a Class II medical device under regulation 872.3310 and adheres to dental-specific standards for restorative materials.

• How is the Austenal Dental Composite Resin supplied for clinical use?

  The Austenal Dental Composite Resin is supplied as a single-use dental material, packaged for direct clinical application. This ensures that each unit is sterile and ready for immediate use in restorative procedures, eliminating the need for additional sterilization steps in the dental office.

• Are there any specific storage requirements for the Austenal Dental Composite Resin?

  While the provided data does not specify detailed storage instructions beyond standard dental practice, it is generally recommended to store dental composite resins in a cool, dry place, protected from direct sunlight and extreme temperatures. Always follow the manufacturer’s guidelines to maintain the material’s integrity and performance.