FDA.report

510(k) K953604

Device
SHAPING HEDSTROM N.T.
Applicant
SYBRON DENTAL SPECIALTIES, INC.
510(k) number
K953604
Product code
EKS  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-28
Date received
1995-08-02
Regulation
872.4565
Classification name
File, Pulp Canal, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JEFFREY A ANDERSON
Address
1332 S. Lone Hill Ave. Glendora CA US 91740 91740

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

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

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