OBA-MCP Orthodontic Bracket Adhesive
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K173020 FDA 510(k)
- FDA Product Code
- DYH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3750 FDA 510(k)
- Regulation Number
- 872.3750 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OBA-MCP Orthodontic Bracket Adhesive is a light-cure composite adhesive designed for the direct and indirect bonding of orthodontic brackets to teeth. It incorporates modified calcium phosphate (MCP) to promote fluoride, calcium, and phosphate ion release, aiding in tooth remineralization. Formulated without Bisphenol A (BPA), BisGMA, or BPA derivatives, it is intended for use in orthodontic treatment to secure brackets securely to prepared tooth surfaces.
This adhesive is supplied as a high-viscosity paste and is used in a clinical setting by dental professionals. It requires application to etched tooth surfaces and bracket bases, followed by firm placement and removal of excess material. The device is classified as a Class II medical device under FDA regulations (872.3750) and has received FDA 510(k) clearance (K173020) as substantially equivalent to a predicate device. It is intended for single-use and must be handled in accordance with standard dental sterilization and infection control protocols.
Frequently asked questions
What is the primary benefit of using the OBA-MCP Orthodontic Bracket Adhesive compared to traditional adhesives?
The OBA-MCP Orthodontic Bracket Adhesive incorporates modified calcium phosphate (MCP), which promotes the release of fluoride, calcium, and phosphate ions. This feature aids in tooth remineralization, potentially helping to strengthen enamel during orthodontic treatment. Additionally, it is formulated without Bisphenol A (BPA), BisGMA, or BPA derivatives, addressing concerns about chemical exposure.
How is the OBA-MCP Orthodontic Bracket Adhesive supplied, and what type of application process does it require?
The OBA-MCP is supplied as a high-viscosity paste, designed for clinical use by dental professionals. The application process involves applying the adhesive to etched tooth surfaces and bracket bases, followed by firmly placing the bracket and removing any excess material. It is a light-cure composite, meaning it requires curing with a dental light to fully set.
Is the OBA-MCP Orthodontic Bracket Adhesive intended for single-use or reusable applications, and how should it be handled?
The OBA-MCP Orthodontic Bracket Adhesive is explicitly intended for single-use only. Like all dental adhesives, it must be handled in accordance with standard dental sterilization and infection control protocols to ensure patient safety and prevent cross-contamination.
What regulatory pathway was followed for FDA clearance of the OBA-MCP Orthodontic Bracket Adhesive, and what classification does it hold?
The OBA-MCP was cleared through the FDA’s 510(k) pathway, specifically under a Traditional Review with the Dental (DE) Advisory Committee. It is classified as a Class II medical device under the FDA’s regulation number 872.3750, with the product code DYH, and was determined to be substantially equivalent to a predicate device.
Does the OBA-MCP Orthodontic Bracket Adhesive come in multiple sizes or models, or is it a single formulation?
The provided data does not specify multiple sizes or models for the OBA-MCP adhesive. It is described as a single high-viscosity paste formulation designed for general orthodontic bracket bonding. For exact application details, refer to the manufacturer’s instructions or technical data sheet.
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: OBA, Orthodontic Bracket Adhesive - PULPDENT, OBA-MCP, Orthodontic Bracket Adhesive with MCP (K173020) — FDA 510(k ..., PDF OBA-MCP, Orthodontic Bracket Adhesive With MCP… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173020 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K173020 24 fields · synced Sep 18, 2026