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510(k) K921771

MINIDAM II by Delsan Dental Systems — Product Code EIE

K921771 is an FDA 510(k) premarket notification submitted by Delsan Dental Systems for the device "MINIDAM II". The FDA issued a decision of Substantially Equivalent on September 17, 1992. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Delsan Dental Systems has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1992
Date Received
April 13, 1992
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 Delsan Dental Systems

  • K921117 — MINIDAM (May 5, 1992)

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