SE Epiphany Root Canal Sealant, Model N59SE

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

510(k) Number

K060889 ↗

FDA Product Code

KIF

Device Class

Class II

Regulation

21 CFR Part 872.3820

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the SE Epiphany Root Canal Sealant, Model N59SE, in endodontic treatment?

  The SE Epiphany Root Canal Sealant, Model N59SE, is specifically designed to seal the root canal system during endodontic procedures. Its purpose is to prevent microbial leakage, which helps maintain the integrity of the root canal filling and supports long-term restoration success by creating a reliable barrier against bacteria and contaminants.

• Is the SE Epiphany Root Canal Sealant intended for single-use or can it be reused?

  The SE Epiphany Root Canal Sealant, Model N59SE, is explicitly supplied as a single-use dental material. This ensures sterility and consistency in clinical settings, as reuse could compromise its performance and safety.

• What type of material is the SE Epiphany Root Canal Sealant made from, and what makes it distinct?

  The SE Epiphany Root Canal Sealant is a resin-based material with a predominant filler of barium boro-silicate glass. This composition contributes to its sealing properties, helping to achieve a durable and effective root canal seal while adhering to regulatory standards for dental materials.

• How is the regulatory status of this device determined, and what does that mean for clinicians?

  The SE Epiphany Root Canal Sealant received FDA 510(k) clearance under the classification of 'Resin, Root Canal Filling' (K060889), with a determination of 'Substantially Equivalent' to a predicate device. This means it has been evaluated and approved as meeting the performance standards required for root canal filling materials, ensuring its safety and effectiveness for clinical use in dental settings.

• Are there multiple models or sizes available for the SE Epiphany Root Canal Sealant?

  The provided data lists multiple registration numbers (e.g., 3002807757, 3003120666) under the product code KIF, which may indicate variations in packaging, batch sizes, or other administrative distinctions. However, the data does not specify distinct clinical sizes or models beyond the single model number (N59SE) mentioned. Clinicians should confirm with the manufacturer for exact variations or customization options.