Home / 510(k) Clearances / K050201

510(k) K050201

AEU-14CF EXPENDITION by Aseptico, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2005
Date Received
January 28, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

Other clearances by Aseptico, Inc.

  • K150129 — AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) (May 28, 2015)
  • 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)
  • K030895 — ASEPTICO ENDOPEX V, MODEL AEU-40 (December 3, 2003)
  • K030163 — ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 (March 3, 2003)

Other clearances for product code EIA

  • K251626 — Midmark Dental Delivery System (November 3, 2025)
  • K251491 — K5 Cart, K5 Mount, K5 Swing (July 17, 2025)
  • K243130 — Integral Dental Unit (June 27, 2025)
  • K242611 — Integral Dental Units (May 27, 2025)
  • K250473 — Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus (February 19, 2025)
  • K242404 — BDC Dental Unit (February 7, 2025)
  • K231297 — Firstar Dental Unit (January 27, 2025)
  • K233805 — K5 (September 3, 2024)
  • K240754 — N2 (March 21, 2024)
  • K231845 — Dental unit Model: Mare (February 28, 2024)