Pulpdent Orthodontic Bracket Adhesive
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K911286 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 Pulpdent Orthodontic Bracket Adhesive is a dental adhesive designed to bond orthodontic brackets to tooth surfaces. Classified as an adhesive, bracket, and tooth conditioner resin, it is a self-cure, two-paste system intended for secure orthodontic applications.
This adhesive is supplied as a high-viscosity paste and is used in a clinical setting for orthodontic procedures. It requires application of approximately ½mm of paste to the bracket base, followed by placement on the tooth with firm pressure, excess removal, and a 10-second light cure on each side. The device is regulated under FDA 510(k) clearance (K911286) and falls under regulation number 872.3750, classified as a Class II medical device.
Frequently asked questions
What is the Pulpdent Orthodontic Bracket Adhesive used for in clinical practice?
The Pulpdent Orthodontic Bracket Adhesive is specifically designed to bond orthodontic brackets securely to tooth surfaces during orthodontic treatment. It is a self-cure, two-paste system that requires application of approximately ½mm of paste to the bracket base, followed by placement on the tooth, firm pressure, excess removal, and a 10-second light cure on each side for optimal adhesion.
How is the Pulpdent Orthodontic Bracket Adhesive supplied, and what does the application process involve?
The adhesive is supplied as a high-viscosity paste in a two-paste system. The application process involves spreading about ½mm of paste onto the bracket base, pressing the bracket firmly onto the tooth, removing any excess material, and curing each side with a 10-second light exposure. This ensures a strong bond for orthodontic treatment.
Is the Pulpdent Orthodontic Bracket Adhesive intended for single-use or can it be reused?
The Pulpdent Orthodontic Bracket Adhesive is designed for single-use in a clinical setting. Once applied to a bracket and cured, it is not intended for reuse, as its purpose is to create a secure bond for orthodontic procedures.
What regulatory pathway does the Pulpdent Orthodontic Bracket Adhesive follow, and what classification does it hold?
The Pulpdent Orthodontic Bracket Adhesive follows the FDA 510(k) clearance pathway and is classified as a Class II medical device under regulation number 872.3750. It was determined to be substantially equivalent to a predicate device and received clearance under the traditional 510(k) review process.
Are there multiple models or sizes available for the Pulpdent Orthodontic Bracket Adhesive?
The provided data lists multiple registration numbers (e.g., 1815540, 3008882689, etc.) under the product code *DYH*, which may indicate variations in packaging, batch sizes, or lot-specific identifiers. However, the adhesive itself is described as a single high-viscosity paste system without explicit mention of distinct sizes or models beyond its two-paste formulation. For precise sizing or model-specific details, refer to the manufacturer’s packaging or technical documentation.
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, Orthodontics Archives - PULPDENT, Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System, OBA Bracket Adhesive (Pulpdent) - Dental supplies selling website
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K911286 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K911286 24 fields · synced Sep 20, 2026