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510(k) K843018

Device
FLEXI-POST
Applicant
ESSENTIAL DENTAL SYSTEMS, INC.
510(k) number
K843018
Product code
ECR  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-27
Date received
1984-08-01
Regulation
872.4565
Classification name
Setter, Band, 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 ECR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951776BAND SEATEROrmco Corp.1995-05-23
K935156DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTSDentauraum, Inc.1994-02-03

Legacy Summary#

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FDA Review#

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