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510(k) K142124

AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM by Aseptico, Inc. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 2014
Date Received
August 4, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by Aseptico, Inc.

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  • K130693 — AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM (August 14, 2013)
  • K111078 — AEU-26L ELCTRONIC ENDODONTIC SYSTEM (June 14, 2011)
  • K101332 — AMC-20 PORTABLE DENTAL CART MODEL AMC-20 (April 11, 2011)
  • K103399 — GENERAL DENISTRY MOTOR (February 28, 2011)
  • K070866 — ASC-12 PIEZOELECTRIC SCALER (April 11, 2007)
  • K051077 — E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101 (May 3, 2005)
  • K050201 — AEU-14CF EXPENDITION (March 18, 2005)
  • K030895 — ASEPTICO ENDOPEX V, MODEL AEU-40 (December 3, 2003)
  • K030163 — ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 (March 3, 2003)

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