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510(k) K150129

AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) by Aseptico, Inc. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 2015
Date Received
January 21, 2015
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.

  • K142124 — AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM (December 31, 2014)
  • 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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