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510(k) K021253

ULTRASONIC TIPS WITH DIAMOND COATING by Sybron Endo/Analytic — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2002
Date Received
April 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Scaler, Ultrasonic
Device Class
Class II
Regulation Number
872.4850
Review Panel
DE
Submission Type

Other clearances by Sybron Endo/Analytic

  • K031664 — ELEMENTS OBTURATION UNIT (April 28, 2004)
  • K021298 — ELEMENTS DIAGNOSTIC UNIT (June 19, 2002)

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