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510(k) K884828

HANDIDAM by Aseptico, Inc. — Product Code EIE

K884828 is an FDA 510(k) premarket notification submitted by Aseptico, Inc. for the device "HANDIDAM". The FDA issued a decision of Substantially Equivalent on February 3, 1989. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Aseptico, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 1989
Date Received
November 18, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dam, Rubber
Device Class
Class I
Regulation Number
872.6300
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)
  • K050201 — AEU-14CF EXPENDITION (March 18, 2005)
  • K030895 — ASEPTICO ENDOPEX V, MODEL AEU-40 (December 3, 2003)

Other clearances for product code EIE

  • K182118 — armor LC (May 3, 2019)
  • K151945 — Triumph Resin Dam (February 18, 2016)
  • K050318 — BARI-KAD PACKING DEVICE (March 4, 2005)
  • K043301 — GC TION GINGIVAL PROTECTOR (January 25, 2005)
  • K040797 — BRITESMILE MASKING CREAM (April 2, 2004)
  • K022522 — PULPDENT PUTTY DAM (September 26, 2002)
  • K021524 — LIGHT CURE DENTAL DAM (July 19, 2002)
  • K021613 — NIVEOUS LIQUID DAM (June 20, 2002)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)

FDA data resources