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510(k) K851716

Device
865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILES
Applicant
ARTIBERIA
510(k) number
K851716
Product code
EMI  
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-11
Date received
1985-04-25
Regulation
872.4565
Classification name
File, Bone, Surgical
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
GIL M SANCHEZ
Address
4518 Los Ranchitos San Antonio TX US 78233 78233

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EMI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K914035MINI-MILLBiomedical Composites, Ltd.1992-03-02
K912989PLANUSTAR AND DENS NOBILIS DENTURE TEETHWilde-USA, Inc.1991-08-16
K823676DISC NEEDLE SET #TX-8220Today'S Machining & Design, Inc.1983-01-09

Legacy Summary#

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FDA Review#

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