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510(k) K812239

Device
UNITEK PALATAL BAR
Applicant
UNITEK CORP.
510(k) number
K812239
Product code
DYT  
Decision
Substantially Equivalent (SESE)
Decision date
1981-09-21
Date received
1981-08-11
Regulation
872.5525
Classification name
Maintainer, Space Preformed, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

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
K935856DENTAURUM SPACE MAINTAINERDentauraum, Inc.1994-04-28
K864376FIBERBONDDentec, Inc.1987-04-07
K780814SAFETY STOP NECKSTRAPNorthwest Orthodontics, Inc.1978-06-30

Legacy Summary#

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FDA Review#

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