Bpa-Free Microhybid Composite

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

510(k) Number

K120237 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Temp F

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  FDA 510(k) K092501 Active Cleared 12 Nov 2009

See all devices from Novocol, Inc. →

• What types of dental restorations is the BPA-Free Microhybrid Composite designed for?

  This composite is specifically formulated for direct esthetic restorations in both anterior (front) and posterior (back) teeth. It is approved for Class I through Class V restorations, including filling cavities, repairing defects, and closing diastema (gaps between teeth). Its microhybrid formulation balances strength and aesthetics, making it versatile for a wide range of clinical scenarios where a durable, visually pleasing repair is needed.

• How is the BPA-Free Microhybrid Composite supplied, and what are its sterility requirements?

  The composite is supplied as a reusable dental material intended for single-patient use per application. To maintain sterility, it must be handled according to manufacturer guidelines, which likely include sterile packaging and proper storage conditions. Since it is not pre-sterilized for multi-patient use, clinicians must ensure it remains uncontaminated before application to avoid cross-infection risks.

• Is the BPA-Free Microhybrid Composite reusable or single-use, and how should it be stored?

  The material is single-use per patient application, though the packaging itself may be reusable for multiple sterile applications if handled correctly. Storage must follow the manufacturer’s instructions to preserve performance integrity, including adherence to expiration dates. Improper storage (e.g., exposure to moisture, extreme temperatures, or light) could compromise its mechanical properties or curing characteristics, reducing clinical effectiveness.

• Does the BPA-Free Microhybrid Composite have any special considerations for MRI safety?

  The regulatory submission for this device does not include any MRI safety considerations, meaning it is not labeled as MRI-safe or MRI-conditional. Clinicians should confirm with the manufacturer if there are specific guidelines for patients requiring MRI scans post-restoration, though the composite itself does not appear to contain metallic or ferromagnetic components that would pose risks during imaging.

• What regulatory pathway does the BPA-Free Microhybrid Composite follow, and what does FDA clearance mean for this product?

  The composite holds an FDA 510(k) clearance (K120237), classified under *Tooth Shade Resin Material* (21 CFR 872.3690). The clearance is based on a determination of substantial equivalence to a predicate device, meaning the FDA found it as safe and effective as an existing, legally marketed alternative. This does not imply it is the only option but confirms it meets regulatory standards for dental restorative materials. Always verify the latest labeling or manufacturer updates for compliance.