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All-Bond Universal SC

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131734

by Bisco Inc.

Identifiers

510(k) Number
K131734 FDA 510(k)
FDA Product Code
KLE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3200 FDA 510(k)
Regulation Number
872.3200 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The All-Bond Universal SC is a resin-based dental adhesive designed for bonding dental restorations to tooth structures. Classified as an agent for tooth bonding, it facilitates durable adhesion between various dental materials and enamel or dentin, ensuring mechanical retention in restorative procedures.

This adhesive is supplied as a single-component system, intended for use in dental offices under aseptic conditions. It is classified as a Class II device under FDA regulations and has received 510(k) clearance for substantial equivalence to a predicate device. The product is non-sterile and must be prepared and applied by trained dental professionals, adhering to standard dental protocols for adhesion.

Frequently asked questions

What types of dental materials can the All-Bond Universal SC adhesive bond to, and how does it ensure durable adhesion?

The All-Bond Universal SC is designed as a resin-based dental adhesive for bonding dental restorations to tooth structures, including both enamel and dentin. It facilitates durable adhesion by creating a strong mechanical bond between various dental materials—such as composites, ceramics, or other restorative resins—and the natural tooth surface, ensuring long-term retention in restorative procedures.

Is the All-Bond Universal SC adhesive single-use or reusable, and how should it be handled in a dental office?

The All-Bond Universal SC is a non-sterile adhesive that must be prepared and applied under aseptic conditions in a dental office. Since it is a single-component system, it is intended for single-use per application, requiring trained dental professionals to follow standard dental protocols for adhesion to maintain sterility and effectiveness.

What regulatory pathway was followed for FDA clearance of the All-Bond Universal SC, and what does this mean for its use in clinical settings?

The All-Bond Universal SC received FDA clearance through a 510(k) submission, classified as a Class II device under substantial equivalence (SESE) to a predicate device. This means the device was determined to be as safe and effective as a previously cleared product, allowing its use in clinical settings under the conditions specified in the clearance, including adherence to dental bonding protocols.

How should the All-Bond Universal SC adhesive be stored, and are there any special handling instructions?

The All-Bond Universal SC is non-sterile and must be stored according to the manufacturer’s guidelines (Bisco Inc.) to preserve its integrity. Since it is a single-component system, it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Proper storage ensures optimal performance when prepared and applied under aseptic conditions in a dental office.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ALL-BOND UNIVERSAL SC (NOT FINALIZED) by BISCO, INC. | FDA 510 (k) Summary, PDF Rx Only - bisco.com, All Bond Universal Adhesive | BISCO, All-Bond Universal Review - Dentist's Verdict (2026)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bisco Inc.
FDA Applicant
Bisco, Inc.

Sources (1)

  • FDA 510(k) K131734 24 fields · synced Sep 19, 2026