Midwest One

FDA 510(k) K955655 · Midwest Dental Products Corp.

Substantially Equivalent

510(k) numberK955655

Submission

Device name
Midwest One
Applicant
Midwest Dental Products Corp.
Des Plaines, IL, US
Received
December 12, 1995
Decision date
March 5, 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
EFB – Handpiece, Air-Powered, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.4200
Specialty
Dental

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More from Ttbio Corp.

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K964755Microjet Cavity Preparation SystemKOJ · Traditional 09/11/1997SE
K962877Midwest 300 SeEFB · Traditional 10/18/1996SE
K963050Tradition P, Push Button HandpieceEFB · Traditional 10/11/1996SE

Questions and answers

When was Midwest One cleared by the FDA?

Midwest One (K955655) received a 510(k) decision of Substantially Equivalent on March 5, 1996, 84 days after the submission was received.

What is the product code of K955655?

The FDA product code is EFB – Handpiece, Air-Powered, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.