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510(k) K843705

Device
Mandibulator Jaw Positioner
Applicant
A COMPANY, INC.
510(k) number
K843705
Product code
DYJ
Decision
Substantially Equivalent (SESE)
Decision date
1984-11-14
Date received
1984-09-21
Regulation
872.5410
Classification name
Retainer, Screw Expansion, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOE MONFREDO
Address
P.O. Box 81247 San Diego CA US 92138 92138

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DYJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K970930BILATERAL INFANT CLEFT PALATE ORTHODONTIC APPLIANCECleft Palate Appliances, Inc.1997-04-23
K935154DENTAURUM EXPANSION SCREWSDentauraum, Inc.1994-02-03
K925088EXPANSION SCREWSForestadent1993-05-22
K912417MOLAR DISTALIZING ASSEMBLYAmerican Orthodontics1991-12-20