Carrara Interaction Ceramic System

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

510(k) Number

K040635 ↗

FDA Product Code

EIH

Device Class

Class II

Regulation

21 CFR Part 872.6660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the Carrara Interaction Ceramic System used for?

  The Carrara Interaction Ceramic System is a powder-based dental veneering ceramic designed specifically for metal-ceramic or full ceramic restorative systems. It bonds to underlying restorative frameworks to create durable and aesthetically pleasing dental restorations, such as crowns, bridges, or inlays. This system is intended for use in dental laboratories and clinical settings where ceramic restorations are fabricated.

• How is the Carrara Interaction Ceramic System supplied and used?

  The system is supplied as a powder-based ceramic material, intended for single-use applications in dental restorative procedures. To achieve proper bonding and aesthetic results, the powder must be processed using a dental furnace during firing. This ensures the ceramic adheres correctly to the framework, forming a strong and visually appealing restoration.

• Is the Carrara Interaction Ceramic System sterile?

  The provided data does not specify sterility information for the Carrara Interaction Ceramic System. Since it is a powder-based material intended for use in dental laboratories and clinical settings, proper handling and processing protocols should be followed to maintain cleanliness and prevent contamination during fabrication.

• What product code and regulatory pathway does this ceramic system follow?

  The Carrara Interaction Ceramic System is classified under product code EIH (Powder, Porcelain) and holds an FDA 510(k) clearance (K040635) under the Traditional review pathway. This clearance was granted on March 30, 2004, and the system is deemed substantially equivalent to a legally marketed predicate device.

• Can this ceramic system be reused?

  No, the Carrara Interaction Ceramic System is explicitly intended for single-use applications. Once processed and fired for a dental restoration, the powder should not be reused, as this could compromise the integrity, bonding quality, and sterility of subsequent restorations.