Trans OBA Orthodontic Bracket Adhesive
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K014059 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 Trans OBA Orthodontic Bracket Adhesive is a dental adhesive designed for bonding orthodontic brackets to tooth surfaces. Classified as an adhesive, bracket, and tooth conditioner, it is a resin-based product intended to provide a secure attachment for orthodontic hardware during treatment.
This light-cure, single-component adhesive paste is supplied in clinical settings for use by dental professionals. It is applied as a thin layer to bracket bases and tooth surfaces, requiring no complex electronics or software. The product is single-use, with no regulatory status implied beyond the stated FDA 510K clearance under classification DYH (Device Type: Dental Hardware)
Frequently asked questions
What is the primary purpose of the Pulpdent Trans OBA Orthodontic Bracket Adhesive, and how does it function in orthodontic treatment?
The Pulpdent Trans OBA Orthodontic Bracket Adhesive is designed specifically to bond orthodontic brackets securely to tooth surfaces. It is a resin-based, light-cure adhesive that requires no complex equipment—just a light source to activate curing. This ensures a strong, reliable attachment of brackets during orthodontic treatment, helping maintain proper alignment of teeth throughout the process.
Is this adhesive intended for single-use only, and if so, why?
Yes, the Pulpdent Trans OBA Orthodontic Bracket Adhesive is explicitly labeled as a single-use product. This classification is due to its clinical setting application, where each patient requires a sterile adhesive to prevent cross-contamination and ensure patient safety. Single-use also aligns with best practices in orthodontics to avoid potential degradation or contamination over time.
How is the adhesive supplied, and what should clinicians expect when handling it?
The Trans OBA Orthodontic Bracket Adhesive is supplied as a single-component, resin-based paste in clinical settings. It is designed for ease of use by dental professionals, requiring no mixing or complex preparation—just application to bracket bases and tooth surfaces before curing with light. The packaging ensures sterility and stability for immediate clinical use.
What regulatory pathway was followed for FDA clearance of this adhesive, and what does that mean for clinicians?
The Pulpdent Trans OBA Orthodontic Bracket Adhesive received FDA clearance through a 510(k) submission, classified under DYH (Dental Hardware) with a Traditional clearance type. This means the product was determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and effectiveness standards for orthodontic adhesives. Clinicians can rely on this clearance as validation of its design and performance for bonding brackets.
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, Pulpdent Trans Oba Orthodontic Bracket Adhesive, OBA™ (Pulpdent) | Dental Product | Pearson Dental
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K014059 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K014059 24 fields · synced Sep 18, 2026