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510(k) K912989

Device
PLANUSTAR AND DENS NOBILIS DENTURE TEETH
Applicant
WILDE-USA, INC.
510(k) number
K912989
Product code
EMI  
Decision
Substantially Equivalent (SESE)
Decision date
1991-08-16
Date received
1991-07-08
Regulation
872.4565
Classification name
File, Bone, Surgical
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ROBERT W BAUER
Address
P.O. Box 4168 Naperville IL US 60567 60567

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
K851716865/1 TO 875/3 VARIOUS TYPES OF DENTAL BONE FILESArtiberia1985-06-11
K823676DISC NEEDLE SET #TX-8220Today'S Machining & Design, Inc.1983-01-09

Legacy Summary#

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FDA Review#

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