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510(k) K912417

Device
MOLAR DISTALIZING ASSEMBLY
Applicant
AMERICAN ORTHODONTICS
510(k) number
K912417
Product code
DYJ  
Decision
Substantially Equivalent (SESE)
Decision date
1991-12-20
Date received
1991-05-31
Regulation
872.5410
Classification name
Retainer, Screw Expansion, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL RIDDLE
Address
1714 Cambridge Ave. Sheboygan WI US 53081 53081

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
K843705MANDIBULATOR JAW POSITIONERA Company, Inc.1984-11-14

Legacy Summary#

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FDA Review#

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