All-Bond Dentin Bonding System
FDA 510(k)Class II (US FDA 510(k))
by Bisco Inc.
Identifiers
- 510(k) Number
- K897020 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 Dentin Bonding System is a dental adhesive classified as an Agent, Tooth Bonding, Resin, designed to create a durable bond between dental restorative materials and tooth structure. It employs a total-etch bonding technique to micro-mechanically bond to dentin and enamel, ensuring compatibility with light-, dual-, and self-cured composite resins. The system is formulated to enhance bond longevity through improved hydrophobicity, supporting long-term restoration integrity.
This system is supplied as a multi-component kit and is intended for single-use in clinical settings. It requires no activation step and is compatible with both direct and indirect restorative techniques. The device is classified under FDA regulation 872.3200 and holds a Traditional 510(k) clearance (K897020) as Substantially Equivalent to a predicate device. Sterility and regulatory compliance are ensured through FDA oversight, with no indication of MRI safety or reusable components in the specifications.
Frequently asked questions
What is the All-Bond Dentin Bonding System used for?
The All-Bond Dentin Bonding System is designed to create a strong, long-lasting bond between dental restorative materials and tooth structure. It uses a total-etch technique to micro-mechanically bond to both dentin and enamel, ensuring compatibility with light-cured, dual-cured, and self-cured composite resins. This helps maintain restoration integrity over time by improving hydrophobicity, which reduces moisture interference.
How is the All-Bond Dentin Bonding System supplied, and is it single-use?
The system is supplied as a multi-component kit, intended exclusively for single-use in clinical settings. This ensures sterility and prevents cross-contamination between patients, aligning with best practices for dental adhesives.
Does the All-Bond Dentin Bonding System require any activation step?
No, the All-Bond Dentin Bonding System does not require an additional activation step. It is formulated to bond directly to prepared tooth surfaces once applied, simplifying the clinical workflow for dentists.
What types of restorative techniques are compatible with this bonding system?
The All-Bond Dentin Bonding System is compatible with both direct and indirect restorative techniques. This versatility makes it suitable for a wide range of dental procedures, including fillings, inlays, and crowns, depending on the clinician’s preference and the restorative material used.
How is sterility ensured for the All-Bond Dentin Bonding System?
Sterility for the All-Bond Dentin Bonding System is maintained through FDA oversight and regulatory compliance. Since it is supplied as a single-use kit, each package is designed to remain sterile until opened in a clinical setting, reducing the risk of contamination.
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 3® Part A&B Set - BISCO, All Bond Universal Adhesive | BISCO, All-Bond Universal Review - Dentist's Verdict (2026)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K897020 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K897020 24 fields · synced Oct 1, 2026