Crystalline C2 and Crystalline L3

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

510(k) Number

K894890 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

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

• Granitec Z2, Zinc Phosphate Cement

  Class II

  FDA 510(k) K896649 Active Cleared 22 Feb 1990

• Trend Set 2 Plus

  Class II

  FDA 510(k) K936070 Active Cleared 4 Feb 1994

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• Are the Crystalline C2 and Crystalline L3 materials intended for single-use or can they be reused in a dental office?

  The Crystalline C2 and Crystalline L3 are supplied as multi-use materials, meaning they are designed for repeated use in dental offices under aseptic conditions. Since they are classified as dental restorative materials (product code EBF), proper handling and storage protocols must be followed to maintain sterility and performance for multiple applications.

• What is the primary difference between the Crystalline C2 and Crystalline L3 in terms of their intended use?

  The Crystalline L3 is explicitly described as a hybrid composite, which suggests it combines properties (such as filler content and resin matrix balance) to enhance performance in dental restorations. While both are used for hybrid composite fillings, the L3 variant is optimized for specific restorative needs, such as improved durability or aesthetics, though the exact clinical distinctions are not detailed in the provided data.

• How should these materials be stored to ensure proper performance and longevity?

  Since the Crystalline C2 and Crystalline L3 are multi-use materials, they must be stored in a way that preserves their integrity and sterility for repeated use. The manufacturer’s instructions (not provided here) should specify conditions like temperature, humidity, and sealing, but generally, dental composites should be kept in a cool, dry place away from direct sunlight and extreme temperatures to prevent degradation or contamination.

• What regulatory pathway was followed for FDA clearance of these dental restorative materials?

  The Crystalline C2 and Crystalline L3 were cleared through the FDA 510(k) process (traditional pathway) under clearance number K894890, with a decision date of October 27, 1989. They fall under 21 CFR 872.3690 and were reviewed by the Dental Devices (DE) Advisory Committee, with a determination of Substantially Equivalent (SESE) to a predicate device. This means their safety and effectiveness were compared to an existing approved dental restorative material.