Fiberfill AGP

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

510(k) Number

K023818 ↗

FDA Product Code

KIF

Device Class

Class II

Regulation

21 CFR Part 872.3820

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Fiberfill Sgp

  Class I

  FDA 510(k) K023819 Active Cleared 26 Mar 2003

• Trionomer

  Class II

  FDA 510(k) K022150 Active Cleared 21 Aug 2002

• SE Epiphany Root Canal Sealant, Model N59SE

  Class II

  FDA 510(k) K060889 Active Cleared 27 Oct 2006

• Avante Led Curing Unit, Model N44

  Class II

  FDA 510(k) K052349 Active Cleared 21 Oct 2005

• Generation 8 Se Adhesive

  Class II

  FDA 510(k) K072480 Active Cleared 21 Nov 2007

• Rm Bond, Model J032

  Class II

  FDA 510(k) K072830 Active Cleared 4 Dec 2007

See all devices from Pentron Clinical Technologies →

• What is the Fiberfill AGP used for in endodontic procedures?

  The Fiberfill AGP is a composite resin specifically formulated for filling the root canal space after pulp removal. Its primary purpose is to create a tight seal within the canal to prevent microbial contamination and support the structural integrity of the tooth during long-term restoration. The radiopaque properties also allow for clear visualization during radiographic imaging, ensuring accurate assessment of the filling.

• How is the Fiberfill AGP supplied and what are its sterility and usage instructions?

  The Fiberfill AGP is supplied as a single-use, sterile material, packaged for one-time clinical use in dental offices by licensed practitioners. Each package is intended for a single procedure to maintain sterility. Proper storage is required to preserve sterility, and it should only be used once per application to avoid cross-contamination.

• Is the Fiberfill AGP reusable or intended for single-use?

  The Fiberfill AGP is explicitly designed for single-use only. It is packaged as a sterile material for one-time clinical application, ensuring safety and sterility per each procedure. Reuse is not recommended or supported by the manufacturer.

• Does the Fiberfill AGP have any special storage requirements?

  The Fiberfill AGP must be stored under conditions that maintain its sterility until use. This typically includes keeping the packaging intact and following manufacturer guidelines for temperature and environmental protection. Avoid exposure to moisture, extreme temperatures, or contamination to ensure the material remains effective and safe for clinical use.

• What regulatory approvals does the Fiberfill AGP hold?

  The Fiberfill AGP holds a 510(k) clearance (K023818) from the FDA, confirming its substantial equivalence to a predicate device for root canal filling applications. It is classified as a Class II medical device under FDA regulation 21 CFR 872.3820, indicating it has undergone rigorous review for safety and effectiveness.