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510(k) K853183

ENDODONTIC ELECTRONIC SPREADER HEATER by Sturgeon Engineering Co. — Product Code EKK

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 16, 1985
Date Received: July 30, 1985
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Spreader, Pulp Canal Filling Material, Endodontic
Device Class: Class I
Regulation Number: 872.4565
Review Panel: DE
Submission Type