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510(k) K894120

MADEGOM LTDA. DENTAL DAM by Madegom — Product Code EIE

K894120 is an FDA 510(k) premarket notification submitted by Madegom for the device "MADEGOM LTDA. DENTAL DAM". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Madegom has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
June 12, 1989
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 Madegom

  • K894119 — MADEGOM LTDA. PENROSE DRAIN TUBING (August 18, 1989)

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