Cyrstalline L3 Multi-Use Hybrid Composite

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

510(k) Number

K946307 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the Crystalline L3 Multi-Use Hybrid Composite used for?

  The Crystalline L3 Multi-Use Hybrid Composite is designed specifically for bonding orthodontic brackets and other dental appliances to teeth. It combines mechanical retention with chemical adhesion to ensure secure placement during orthodontic treatment, improving stability and longevity of the bonded appliances.

• Is the Crystalline L3 Multi-Use Hybrid Composite intended for single-use or multi-use?

  This device is explicitly labeled for multi-use in dental settings. It is formulated to be reused according to clinical protocols, allowing for cost-effective application across multiple patients while maintaining performance standards.

• Is the Crystalline L3 Multi-Use Hybrid Composite sterile at the time of shipment?

  No, the Crystalline L3 Multi-Use Hybrid Composite is not sterile at the time of shipment. It must be prepared and used following standard dental clinical protocols to ensure proper sterility before application, adhering to best practices for patient safety.

• What regulatory pathway and classification does this device follow?

  The Crystalline L3 Multi-Use Hybrid Composite is classified under product code EBF (Adhesive, Bracket, and Tooth Conditioner) and received FDA 510(k) clearance through the Traditional pathway. It was determined to be Substantially Equivalent (SESE) to a predicate device, with review conducted by the Dental Advisory Committee (DE).

• How should the Crystalline L3 Multi-Use Hybrid Composite be stored?

  While the device specifications do not detail storage conditions explicitly, multi-use dental materials like this typically require storage in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines and clinical protocols to maintain the material’s integrity and performance for reuse.