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510(k) K864572

Device
FIXTECTOR
Applicant
PRODENT INTL., INC.
510(k) number
K864572
Product code
EFH  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-12
Date received
1986-11-20
Regulation
872.6140
Classification name
Paper, Articulation
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
STEPHEN A BENT
Address
111 N. Alfred St. P.O. Box 299 Alexandria VA US 22313 22313

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EFH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K965026PFINGST PRESSURE PASTEPfingst & Co., Inc.1997-02-10
K912632OCCLUDEPascal Co., Inc.1992-01-17
K911259HYDENTPascal Co., Inc.1991-06-06
K870032REVISED T-SCAN SYSTEMSentek, Inc.1987-02-02
K832647ARTICULATING PAPERArdent Intl., Inc.1984-02-21
K833132MUCOSAL ADJUSTMENT PASTE LIQUID SPRAYMyo-Tronics Research, Inc.1984-02-10
K810498CENTRIC (BITE) REGISTRATION PASTEWallace A. Erickson & Co.1981-03-17
K771011ARTICULATING PAPERParker Laboratories, Inc.1977-06-20
K770492CRACK DETECTOR, DEN-MATDey-Mat, Inc.1977-03-21

Legacy Summary#

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FDA Review#

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