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510(k) K031809

Device
PERIO PROTECT TRAY
Applicant
PERIO PROTECT LLC
510(k) number
K031809
Product code
KMT  
Decision
Substantially Equivalent (SESE)
Decision date
2004-01-23
Date received
2003-06-12
Regulation
872.6870
Classification name
Tray, Fluoride, Disposable
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAVID L ROSEN
Address
1625 Massachusetts Ave. Nw; Suite 300 Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KMT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K904914DENTAL VACUUM INJECTION TRAYThe Lebanon Vac-Tray Corp.1990-12-17
K871784TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLIColgate-Hoyt Laboratories1987-05-27
K853882SUPER SLICKTang Products1985-11-18
K820104NUPRO* GEL TRAYJohnson & Johnson Professionals, Inc.1982-02-23
K811154HOYT ECONO-TRAYHoyt Laboratories1981-05-13
K780712KERR DISCOVERY DISPOSABLE FLUORIDE TRAYKerr Corporation (Danbury)1978-05-17
K770064FLUORIDE GEL DISPOSABLE TRAYLorvic Corp.1977-01-14

Legacy Summary#

summary

FDA Review#

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