Pulpdent No-Mix Orthodontic Bracket Adhesive
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K014133 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 No-Mix Orthodontic Bracket Adhesive is a fluoride-releasing, self-cure resin adhesive designed for bonding orthodontic brackets to tooth enamel. Classified as an adhesive, bracket, and tooth conditioner, resin (product code DYH), it facilitates secure attachment of brackets during orthodontic treatment by promoting adhesion through a chemical curing process.
This system is supplied as a multi-component kit, including the adhesive, a liquid primer, and a 38% phosphoric acid etching gel, intended for use in clinical dental settings. It is classified as a Class II medical device under FDA regulation 872.3750 and has received FDA 510(k) clearance (K014133) as substantially equivalent to a predicate device. The adhesive is single-use and requires proper storage to maintain sterility and performance.
Frequently asked questions
What is the primary purpose of the Pulpdent No-Mix Orthodontic Bracket Adhesive, and how does it differ from traditional orthodontic adhesives?
The Pulpdent No-Mix Orthodontic Bracket Adhesive is specifically designed to bond orthodontic brackets securely to tooth enamel using a fluoride-releasing, self-cure resin system. Unlike traditional adhesives that may require mixing components, this system simplifies application by eliminating the need for manual mixing, while still promoting strong adhesion through a chemical curing process. The fluoride release also helps protect teeth during orthodontic treatment.
Is this adhesive single-use, and if so, what does that mean for clinical workflow?
Yes, the Pulpdent No-Mix Orthodontic Bracket Adhesive is intended for single-use only. This means each kit is designed for one application per patient, ensuring sterility and performance are maintained for optimal clinical outcomes. Clinicians should open the kit immediately before use and discard any unused portions after application to avoid contamination or degradation of the adhesive properties.
What components are included in the kit, and why is each one necessary for proper use?
The kit includes three key components: the adhesive itself, a liquid primer, and a 38% phosphoric acid etching gel. The primer prepares the tooth surface for optimal adhesion, while the etching gel conditions the enamel by creating a micro-rough texture, which enhances the bond strength of the adhesive. Together, these components ensure a secure and durable attachment of orthodontic brackets during treatment.
How should the adhesive be stored to maintain its sterility and effectiveness?
The adhesive must be stored properly to preserve sterility and performance. Since it is a single-use product, it should be kept in its original, unopened packaging until ready for use. Storage conditions should follow the manufacturer’s guidelines, typically in a cool, dry place away from direct sunlight or extreme temperatures, as exposure to these factors could compromise the adhesive’s properties before application.
What regulatory pathway was followed for FDA clearance, and what does that mean for clinicians using this product?
The Pulpdent No-Mix Orthodontic Bracket Adhesive received FDA 510(k) clearance under the Traditional pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it is as safe and effective as a previously cleared orthodontic adhesive, ensuring it meets regulatory standards for use in clinical dental settings. Clinicians can rely on this clearance as an indication of the product’s compliance with FDA requirements for dental adhesives.
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 No-mix Orthodontic Bracket Adhesive, K014133 - PULPDENT NO-MIX ORTHODONTIC BRACKET ADH... | FDA 510(k), PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE 510(k) K014133 - 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 | K014133 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K014133 24 fields · synced Sep 18, 2026