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510(k) K891338

Device
SMYLON (DENTAL STAIN ERASER)
Applicant
THE SMYLON CO.
510(k) number
K891338
Product code
MAU  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-14
Date received
1989-03-13
Regulation
872.6855
Classification name
Eraser, Dental Stain
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRANK COPPOLA
Address
7366 Waring Ave. Los Angeles CA US 90046 90046

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MAU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K000140CLINI-DENTThe Precident Group2000-05-03

Legacy Summary#

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FDA Review#

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