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510(k) K004031

NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES by Dental Power, Inc. — Product Code EKS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2001
Date Received
December 28, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
File, Pulp Canal, Endodontic
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

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