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Interface Bonding System

by Smile Horizons, Inc.

510(k) K896769

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896769 Date15 May 1990ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Interface Bonding System is a dental bonding device classified under product code EBF, designed for creating secure adhesive interfaces in restorative and prosthetic procedures. It facilitates the bonding of dental materials to tooth structures or restorations, ensuring durable and stable attachments in clinical applications. This system is intended for use in orthodontic, restorative, and fixed prosthodontics to enhance the longevity of dental treatments.

This device is supplied as a reusable system and is intended for use in dental offices under aseptic conditions. It is not classified as single-use and requires proper sterilization between procedures. The Interface Bonding System was cleared by the FDA via a 510(k) submission (K896769) under the Dental advisory committee, with a decision of Substantially Equivalent (SESE) dated May 15, 1990. No specific MRI safety or sterility guarantees are stated in the available data.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Interface Bonding System used for in dental procedures?

    The Interface Bonding System is designed to create secure adhesive interfaces between dental materials and tooth structures or restorations. It is specifically intended for use in orthodontic treatments, restorative dentistry, and fixed prosthodontics to ensure long-lasting and stable attachments, thereby enhancing the longevity of dental treatments.

  • Is the Interface Bonding System single-use or reusable?

    The Interface Bonding System is supplied as a reusable device. It is intended for use in dental offices under aseptic conditions and requires proper sterilization between procedures to maintain safety and efficacy.

  • How should the Interface Bonding System be stored?

    While specific storage instructions are not detailed in the provided data, reusable medical devices like this typically require clean, dry storage in a sealed container or packaging to prevent contamination. Ensure the device is fully sterilized before storage if it has been used, following manufacturer guidelines for sterilization methods (e.g., autoclave or chemical sterilization).

  • What regulatory clearance does the Interface Bonding System hold?

    The Interface Bonding System was cleared by the FDA through a 510(k) submission (K896769) under the Dental advisory committee. The clearance was granted as Substantially Equivalent (SESE) on May 15, 1990, indicating it meets regulatory standards comparable to a predicate device.

  • Are there any special considerations for using this system in clinical settings?

    Since the system is reusable, clinical staff must adhere to strict aseptic protocols during use and sterilization to prevent cross-contamination. The device is not labeled as MRI-safe, so clinicians should verify compatibility with their facility’s MRI protocols if needed. Always follow the manufacturer’s instructions for proper handling, sterilization, and clinical application.