FDA.reportPublic FDA data

510(k) K071615

Device
FIXAFLOSS
Applicant
SYBRON DENTAL SPECIALTIES, INC.
510(k) number
K071615
Product code
EEF  
Decision
Substantially Equivalent (SESE)
Decision date
2007-09-21
Date received
2007-06-13
Regulation
872.6300
Classification name
Clamp, Rubber Dam
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
COLLEEN BOSWELL
Address
1717 W. Collins Ave. Orange CA US 92867 92867

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EEF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K915207DISPOSABLE RADIOLUCENT RUBBER DAM CLAMPBay Technical Products, Inc.1992-02-14
K780744BRINKER TISSUE RETRACTORSHygienic Dental Mfg., Co., The1978-05-12

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases