Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SmarTemp X1

K-Number: K190930 · 2019-09-05

ApplicantParkell, Inc.
Decision Date2019-09-05
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SmarTemp X1 is a medical device manufactured by Parkell, Inc.. It received FDA 510(k) clearance on 2019-09-05 under approval number K190930. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SmarTemp X1?

SmarTemp X1 is a medical device that received FDA 510(k) clearance on 2019-09-05. It is manufactured by Parkell, Inc.. The 510(k) number is K190930.

When was SmarTemp X1 approved by the FDA?

SmarTemp X1 received FDA 510(k) clearance on 2019-09-05, under approval number K190930.

What company makes SmarTemp X1?

SmarTemp X1 is manufactured by Parkell, Inc..

What is the FDA product code for SmarTemp X1?

The FDA product code for SmarTemp X1 is EBG.

Other Devices by Parkell, Inc.

K172176Parkell Universal Adhesive K182296HyperFil-LV K191103Parkell Desensitizer Gel K210259Parkell Self-Adhesive Cement K243254Parkell Pit and Fissure Sealant

Related Devices (Code: EBG)

K153490DD medical polymersDental Direkt GmbH K152443Vericore Gradient Temporary DiscWhip Mix Corporation K153753TelioCAD MultiIvoclar Vivadent, Inc. K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLORDentalplus GmbH K171729Fixtemp C&BDreve Dentamid GmbH K172281PuRE PMMA DiscQuest Dental USA Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑