Medtrol Dental Kit

FDA 510(k) K953707 · Medtrol, Inc.

Substantially Equivalent

510(k) numberK953707

Submission

Device name
Medtrol Dental Kit
Applicant
Medtrol, Inc.
Inverness, IL, US
Received
August 8, 1995
Decision date
January 4, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
EKJ – Burnisher, Operative
Device class
Class I (low risk)
Regulation
21 CFR 872.4565
Specialty
Dental

Other 510(k)s with product code EKJ

510(k)DeviceApplicantDecision
K961714Aseptylum, Uni-CarrierEKJ · Traditional Distriflor S.A.06/10/1996SE
K945815Dental KitEKJ · Traditional Constancy Ent., Inc.07/19/1995SE
K951607Sureflex FilesEKJ · Traditional Dentsply Intl.06/22/1995SE
K945077Instrument,Filling,Plastic,DentalEKJ · Traditional Worldwide Dental, Inc.11/30/1994SE
K943820Stat PakEKJ · Traditional Magnum Instruments, Inc.11/02/1994SE
K943351Maunal Disposable Dental InstrumentsEKJ · Traditional Magnum Instruments, Inc.10/07/1994SE
K943584Presterilized Endodontic FilesEKJ · Traditional Dentsply Intl.09/21/1994SE
K935127Southland Sterile Dental SystemEKJ · Traditional Southland, Ltd.07/28/1994SE
K941954Non-Fogging Dental MirrorEKJ · Traditional Buffalo Dental Mfg. Co., Inc.07/08/1994SE
K925115Amd Dentist and Hygienist KitsEKJ · Traditional Advance Medical Designs, Inc.07/05/1994SE

Questions and answers

When was Medtrol Dental Kit cleared by the FDA?

Medtrol Dental Kit (K953707) received a 510(k) decision of Substantially Equivalent on January 4, 1996, 149 days after the submission was received.

What is the product code of K953707?

The FDA product code is EKJ – Burnisher, Operative, a Class I (low risk) device regulated under 21 CFR 872.4565.