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SmarTemp X1

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K190930

by Parkell, Inc.

Identifiers

510(k) Number
K190930 FDA 510(k)
FDA Product Code
EBG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SmarTemp X1 is a dental temperature monitoring device designed for intraoral use. It provides real-time thermal feedback during dental procedures, ensuring precise temperature control for materials such as composites, cements, and other dental restorative agents.

This device is intended for single-use in clinical settings, including dental offices and clinics. Supplied sterile, it adheres to FDA 510(k) clearance under the dental product code EBG, with regulatory compliance also meeting the requirements of the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device is non-magnetic and safe for use in non-MRI environments.

Frequently asked questions

What types of dental procedures is the SmarTemp X1 designed to assist with, and why is temperature control important in those cases?

The SmarTemp X1 is designed to monitor and control temperature during procedures involving dental restorative materials like composites and cements. Temperature control is critical in these cases because overheating can compromise the integrity of the material, leading to poor bonding, premature failure, or even damage to surrounding dental structures. Real-time feedback from the SmarTemp X1 ensures optimal curing conditions, improving the longevity and success of the restoration.

Is the SmarTemp X1 reusable, or is it intended for single-use only? How does this affect its clinical workflow?

The SmarTemp X1 is explicitly designed for single-use only, which aligns with clinical best practices for infection control and sterility. This means each device is pre-sterilized and intended for one procedure, eliminating the need for cleaning, reprocessing, or sterilization between uses. Clinicians can simply open a new unit, attach it to their dental instrument, and proceed without additional preparation steps, streamlining workflow and reducing cross-contamination risks.

What storage conditions should be followed for the SmarTemp X1 to maintain its performance and sterility?

Since the SmarTemp X1 is supplied sterile, it should be stored in its original, unopened packaging until ready for use. The packaging is likely designed to protect the device from contamination and environmental factors like moisture or extreme temperatures. Clinicians should store it in a clean, dry area away from direct sunlight or sources of heat, following the manufacturer’s guidelines to preserve sterility and functionality until the device is needed for a procedure.

Are there different sizes or models of the SmarTemp X1, or is it a one-size-fits-all device for intraoral use?

The provided data does not specify multiple sizes or models for the SmarTemp X1, suggesting it is likely designed as a universal intraoral device for general dental temperature monitoring. However, clinicians should confirm compatibility with their specific dental instruments or procedures, as some applications may require adaptors or attachments not detailed in the summary. Always refer to the manufacturer’s instructions for proper use.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Parkell, Inc.

Sources (2)

  • FDA 510(k) K190930 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026