510(k) K853183

Device: Endodontic Electronic Spreader Heater
Applicant: STURGEON ENGINEERING CO.
510(k) number: K853183
Product code: EKK
Decision: Substantially Equivalent (SESE)
Decision date: 1985-10-16
Date received: 1985-07-30
Regulation: 872.4565
Classification name: Spreader, Pulp Canal Filling Material, Endodontic
Medical specialty: Dental
Review panel: Dental
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: WILLIAM STURGEON
Address: 1 Innovation Rd. Petrolia CA US 95558 95558

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA