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510(k) K951776

Device
BAND SEATER
Applicant
ORMCO CORP.
510(k) number
K951776
Product code
ECR  
Decision
Substantially Equivalent (SESE)
Decision date
1995-05-23
Date received
1995-04-13
Regulation
872.4565
Classification name
Setter, Band, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY A ANDERSON
Address
1332 S. Lone Hill Ave. Glendora CA US 91740 91740

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ECR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K935156DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTSDentauraum, Inc.1994-02-03
K843018FLEXI-POSTEssential Dental Systems, Inc.1984-09-27

Legacy Summary#

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FDA Review#

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