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

FDA 510(k)

MEDTROL DENTAL KIT

K-Number: K953707 · 1996-01-04

ApplicantMedtrol, Inc.
Decision Date1996-01-04
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEDTROL DENTAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medtrol, Inc.. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K953707. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDTROL DENTAL KIT?

MEDTROL DENTAL KIT is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Medtrol, Inc.. The 510(k) number is K953707.

When did MEDTROL DENTAL KIT receive FDA 510(k) clearance?

MEDTROL DENTAL KIT received FDA 510(k) clearance on 1996-01-04, under 510(k) number K953707.

Who is the listed applicant for MEDTROL DENTAL KIT?

The FDA 510(k) record lists Medtrol, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDTROL DENTAL KIT?

The FDA product code for MEDTROL DENTAL KIT is EKJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: EKJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, Inc.K943351MAUNAL DISPOSABLE DENTAL INSTRUMENTSMagnum Instruments, Inc.

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.

↑