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510(k) K123139

ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES by Asi Medical, Inc. — Product Code ELC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2013
Date Received
October 5, 2012
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

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  • K974487 — SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020 (February 18, 1998)
  • K932873 — SEAC MOBILE UNIT BY ASI MEDICAL (March 7, 1994)

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