Resilience C2, Resilience L3 & Resilience P4

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

510(k) Number

K891464 ↗

FDA Product Code

DYH

Device Class

Class II

Regulation

21 CFR Part 872.3750

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Orthodontic Bracket Adhesive Resin Material

  Class II

  FDA 510(k) K914317 Active Cleared 26 Mar 1992

• Surgi Pak Ne and Cocoment Eugenal Free Paste Syst

  Class II

  FDA 510(k) K902817 Active Cleared 28 Aug 1990

• Porcelain Primer

  Class II

  FDA 510(k) K920534 Active Cleared 26 Mar 1992

• Cyrstalline L3 Multi-Use Hybrid Composite

  Class II

  FDA 510(k) K946307 Active Cleared 26 Jan 1995

• Crystalline C2 and Crystalline L3

  Class II

  FDA 510(k) K894890 Active Cleared 27 Oct 1989

• Granitec Z2, Zinc Phosphate Cement

  Class II

  FDA 510(k) K896649 Active Cleared 22 Feb 1990

See all devices from Confi-Dental Products Co. →

• What are the Resilience C2, L3, and P4 adhesives used for?

  The Resilience C2, Resilience L3, and Resilience P4 are adhesive resins specifically designed for orthodontic applications. They function as bonding agents to securely attach orthodontic brackets to teeth, ensuring a durable and stable bond throughout treatment. Each variant (C2, L3, P4) may have slight formulation differences, as outlined in the manufacturer’s documentation, to optimize performance for different clinical scenarios.

• Are these adhesives single-use or reusable?

  The Resilience C2, L3, and P4 adhesives are supplied as single-use items. This design ensures patient safety and sterility, as each package is intended for one-time use in a dental office setting by trained professionals. Reusing these adhesives is not recommended due to potential contamination risks and degradation of bonding properties.

• Are the Resilience adhesives sterile?

  No, the Resilience adhesives are not sterile products. However, they are packaged to maintain sterility until the first use. This means they are intended to be opened and used immediately in a controlled dental environment, minimizing exposure to contaminants before application.

• What regulatory classification do these adhesives hold?

  The Resilience C2, L3, and P4 adhesives are classified as Class II medical devices under FDA regulations. They fall under the product code DYH (Adhesive, Bracket, and Tooth Conditioner) and comply with special controls for orthodontic adhesives. This classification reflects their role in securing orthodontic brackets to teeth and ensures they meet stringent performance and safety standards.

• How should these adhesives be stored?

  The Resilience adhesives should be stored according to the manufacturer’s instructions, which typically include keeping them in a cool, dry place, away from direct sunlight and extreme temperatures. Proper storage ensures the integrity of the adhesive properties and prevents premature degradation. Always refer to the packaging or accompanying documentation for specific storage guidelines.