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FDA 510(k)

Insight Dental System

K-Number: K170211 · 2017-04-27

ApplicantInsight Dental System
Decision Date2017-04-27
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Insight Dental System is a medical device manufactured by Insight Dental System. It received FDA 510(k) clearance on 2017-04-27 under approval number K170211. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Insight Dental System?

Insight Dental System is a medical device that received FDA 510(k) clearance on 2017-04-27. It is manufactured by Insight Dental System. The 510(k) number is K170211.

When was Insight Dental System approved by the FDA?

Insight Dental System received FDA 510(k) clearance on 2017-04-27, under approval number K170211.

What company makes Insight Dental System?

Insight Dental System is manufactured by Insight Dental System.

What is the FDA product code for Insight Dental System?

The FDA product code for Insight Dental System is DZE.

Related Clinical Trials

NCT07598604 Early Mobilization and Equinus Correction in Spastic Cerebral Palsy NOT_YET_RECRUITING NCT07585812 Comfort-in Needle-Free Injection System in Pediatric Dental Anesthesia COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07581249 This Study Evaluate the Patient Response to Jet Injection, Pain and Satisfaction Compared to Conventional Method of Local Anasthesia Especially in Maxillary Teeth COMPLETED NCT05883202 Effect of the Abutment-Prosthesis Connection on Marginal Bone Loss and Gingival Sealing Around Dental Implants SUSPENDED NCT06970171 Acceptance of Mandibular Advancement Devices ENROLLING_BY_INVITATION

Related Devices (Code: DZE)

K160475Ritter Dental Implant SystemRitter Implants GmbH & Co. KG K161244s-Clean OneQ-SL Narrow Implant SystemDentis Co., Ltd. K163043Zeramex P6 Dental Implant SystemDentalpoint AG K161497Dental Implants and AbutmentsDitron Precision, Ltd. K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc. K151970KJ Mini Implant SystemKj Meditech Co., Ltd.

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.

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