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510(k) K925064

Device
RELAX-O-GUARD
Applicant
AQUATEMP SERVICE CO., INC.
510(k) number
K925064
Product code
KMY  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1993-09-13
Date received
1992-10-06
Regulation
872.5525
Classification name
Positioner, Tooth, Preformed
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAUL J DUDECK
Address
58-C S. St. Morristown NJ US 07960 07960

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KMY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931615NITE-GUIDEORTHO-TAIN, Inc.1995-04-14
K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.1995-02-13
K924351GLENROE ELASTIBITE STIMULATORGlenroe Technologies1994-01-06
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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