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510(k) K931615

Device
NITE-GUIDE
Applicant
ORTHO-TAIN, INC.
510(k) number
K931615
Product code
KMY  
Decision
Substantially Equivalent (SESE)
Decision date
1995-04-14
Date received
1993-04-01
Regulation
872.5525
Classification name
Positioner, Tooth, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAY E RICKELMAN
Address
85th Floor Sears Tower Chicago IL US 60606 60606

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KMY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.1995-02-13
K924351GLENROE ELASTIBITE STIMULATORGlenroe Technologies1994-01-06
K925064RELAX-O-GUARDAquatemp Service Co., Inc.1993-09-13
K924975THE ORTHOTRAINERMyofunctional Research Corp. Pty. , Ltd.1993-07-08
K924974THE TMJ APPLIANCEMyofunctional Research Corp. Pty. , Ltd.1993-06-23
K904128PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONERAmerican Orthodontics1990-11-09
K891328PREFORMED TEMPLATE FOR TOOTH POSITIONERAmerican Orthodontics1989-03-31
K833455REMOLDABLE CRANIOMANDIBULAR APPLIANCEJeffrey H. Attlin1984-01-10
K831793AQUALIZER MOUTHPIECEMartin D. Lerman1983-08-12
K821458DYNAMIC FUNTIONAL POSITIONERDynamic Functional Positioner, Inc.1982-06-09
K780619PREFORMED TOOTH POSITIONERTp Laboratories, Inc.1978-06-28

Legacy Summary#

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FDA Review#

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