510(k) K781919

Device
PLAQUE DETECTION SYSTEM
Applicant
CLAIROL, INC.
510(k) number
K781919
Product code
NYH  
Decision
Substantially Equivalent (SESE)
Decision date
1978-12-04
Date received
1978-11-13
Regulation
872.1740
Classification name
Plaque Disclosing Kit
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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