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510(k) K935152

Device
DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARD
Applicant
DENTAURAUM, INC.
510(k) number
K935152
Product code
DYO  
Decision
Substantially Equivalent (SESE)
Decision date
1994-01-31
Date received
1993-10-28
Regulation
872.5410
Classification name
Band, Material, 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 DYO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931980STAINLESS STEEL ORTHODONTIC PRODUCTSOrtho Organizers, Inc.1993-09-01
K844034SONOCAREEcho Ultrasound1985-01-23

Legacy Summary#

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FDA Review#

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