Monobond S

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

510(k) Number

K905220 ↗

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 clinical applications is the Monobond S adhesive system intended for in dental procedures?

  The Monobond S is specifically designed for bonding dental restorations to tooth structure, ensuring secure attachment of materials like composites, ceramics, and other restorative substances to both enamel and dentin. It is used in clinical dental settings to improve the longevity and stability of restorations.

• Is the Monobond S adhesive system supplied as a single-use or reusable kit, and what does this mean for clinical workflow?

  The Monobond S is supplied as a reusable kit, meaning it is intended for repeated use within a clinical setting. This allows dental professionals to access all necessary components for bonding procedures without the need for individual single-use items, streamlining workflow and reducing waste.

• How was the FDA clearance for the Monobond S adhesive system determined, and what does this mean for its regulatory standing?

  The Monobond S received FDA 510(k) clearance under the product code EBF, with a decision dated December 17, 1990. The clearance was granted as ‘Substantially Equivalent’ to a predicate device, meaning the FDA determined it had the same intended use and technological characteristics as a previously approved product. This classification does not imply ongoing regulatory changes but confirms its compliance with existing standards at the time of approval.

• What should clinicians consider regarding sterility and handling when using the Monobond S adhesive system in their practice?

  The available data does not specify whether the Monobond S is sterile or non-sterile, so clinicians should follow standard dental infection control protocols when handling the reusable kit. Proper cleaning, disinfection, and storage procedures are essential to maintain safety and efficacy between uses, as the system is intended for clinical reuse.