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510(k) K000140

Device
CLINI-DENT
Applicant
THE PRECIDENT GROUP
510(k) number
K000140
Product code
MAU  
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-03
Date received
2000-01-18
Regulation
872.6855
Classification name
Eraser, Dental Stain
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
WENDY BEDALE
Address
200 Westpark Corporate Center 4364 S. Alston Ave. Durham NC US 27713 27713

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MAU  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K891338SMYLON (DENTAL STAIN ERASER)The Smylon Co.1989-11-14

Legacy Summary#

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FDA Review#

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