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Pulpdent Touchdown

FDA 510(k)

Class II (US FDA 510(k))

510(k) K953217

by Pulpdent Corporation

Identifiers

510(k) Number
K953217 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 Touchdown is an Adhesive, Bracket, and Tooth Conditioner, Resin, classified under product code DYH. This dental device is designed to prepare tooth surfaces for bonding procedures, ensuring optimal adhesion of brackets, restorations, or other orthodontic appliances by conditioning enamel and promoting durable bonding.

Supplied as a single-use resin conditioner, the Pulpdent Touchdown is intended for use in clinical dental settings. It is regulated under FDA 510(k) clearance (K953217) and falls under Class II with special controls. The device is not sterile and must be stored in a dry, temperature-controlled environment as specified by the manufacturer. No MRI safety information is provided.

Frequently asked questions

What is the Pulpdent Touchdown specifically used for in a dental setting?

The Pulpdent Touchdown is designed to prepare tooth surfaces for bonding procedures. It conditions enamel to ensure optimal adhesion of brackets, restorations, or other orthodontic appliances, promoting durable bonding during clinical treatments.

Is the Pulpdent Touchdown meant for single-use or can it be reused?

The Pulpdent Touchdown is explicitly supplied as a single-use resin conditioner, meaning each unit is intended for one application only to maintain sterility and effectiveness.

How should the Pulpdent Touchdown be stored to preserve its integrity?

The device must be stored in a dry, temperature-controlled environment as specified by the manufacturer. This ensures proper handling and prevents degradation before use.

Does the Pulpdent Touchdown come in multiple sizes or models?

The provided data lists multiple registration numbers (e.g., 1815540, 3008882689) under the product code DYH, which may indicate variations in packaging or batch sizes, but no specific size or model distinctions are described in the details. Contact Pulpdent Corporation for details on available variants.

Is the Pulpdent Touchdown sterile, and if not, what precautions should be taken?

The Pulpdent Touchdown is not sterile, so standard dental aseptic techniques must be followed during use. This includes proper hand hygiene, use of gloves, and adherence to clinical infection control protocols to minimize contamination risks.

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 TOUCHDOWN (K953217) - FDA 510 (k), PULPDENT ® Corporation - Advancing Dentistry Together, Pulpdent Touchdown 510 (k) FDA Premarket Notification K953217 PULPDENT ..., Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K953217 24 fields · synced Sep 20, 2026