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510(k) K935154

Device
DENTAURUM EXPANSION SCREWS
Applicant
DENTAURAUM, INC.
510(k) number
K935154
Product code
DYJ  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-03
Date received
1993-10-28
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
JOHN J ROTH, JR
Address
10 Pheasant Run Newtown PA US 18940 18940

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
K925088EXPANSION SCREWSForestadent1993-05-22
K912417MOLAR DISTALIZING ASSEMBLYAmerican Orthodontics1991-12-20
K843705MANDIBULATOR JAW POSITIONERA Company, Inc.1984-11-14

Legacy Summary#

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FDA Review#

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