Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K020115 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)
This device is an Adhesive, Bracket and Tooth Conditioner, Resin, classified under FDA regulation 872.3750. It is a self-cure, two-paste system designed to bond orthodontic brackets to tooth surfaces, ensuring secure attachment for orthodontic treatment.
The system is supplied as a clinical-grade adhesive for use by dental professionals in a controlled setting. It consists of a high-viscosity paste applied to bracket bases, which requires firm placement and excess removal before optional light curing. The adhesive is intended for single-use and is regulated under FDA 510(k) clearance (K020115) as a Class II device.
Frequently asked questions
Is this adhesive system reusable or intended for single-use only?
This system is explicitly designed for single-use only. The description specifies it is a clinical-grade adhesive intended for use by dental professionals in a controlled setting, with no indication of reprocessing or reuse. Single-use ensures sterility and consistency in orthodontic bracket adhesion.
How is this adhesive system applied, and does it require light curing?
The system is a self-cure, two-paste adhesive applied to bracket bases. After placement, excess adhesive must be removed before an optional light-curing step. The self-cure mechanism ensures bonding without light curing, though curing can be used for added strength if preferred.
What types of brackets does this adhesive system work with, and are there specific sizes or models?
The system is universally designed for orthodontic brackets but does not specify particular sizes or models in the provided data. The high-viscosity paste is intended for secure attachment to tooth surfaces, so compatibility depends on bracket base design rather than a fixed size range. Always verify bracket manufacturer guidelines for optimal use.
How should this adhesive system be stored, and is sterility maintained?
As a clinical-grade adhesive, this system is likely packaged in a sterile format suitable for single-use in dental settings. Storage instructions are not detailed in the data, but standard practice for adhesives of this type includes keeping it in a cool, dry place away from direct sunlight until use. Sterility is preserved until the package is opened.
What regulatory pathway was followed for this adhesive system’s approval?
This device was cleared through the FDA’s 510(k) process under Traditional Review by the Dental Devices Panel (DE). The clearance (K020115) was granted in 2002, with a Substantially Equivalent determination, confirming it meets FDA standards for Class II orthodontic adhesives. The product code (DYH) aligns with dental orthodontic devices.
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: Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System, OBA, Orthodontic Bracket Adhesive - PULPDENT, PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K020115 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K020115 24 fields · synced Sep 18, 2026