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510(k) K935856

Device
DENTAURUM SPACE MAINTAINER
Applicant
DENTAURAUM, INC.
510(k) number
K935856
Product code
DYT  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-28
Date received
1993-12-08
Regulation
872.5525
Classification name
Maintainer, Space Preformed, 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 DYT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K864376FIBERBONDDentec, Inc.1987-04-07
K812239UNITEK PALATAL BARUnitek Corp.1981-09-21
K780814SAFETY STOP NECKSTRAPNorthwest Orthodontics, Inc.1978-06-30

Legacy Summary#

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FDA Review#

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