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510(k) K151945

Triumph Resin Dam by Denali Corporation — Product Code EIE

K151945 is an FDA 510(k) premarket notification submitted by Denali Corporation for the device "Triumph Resin Dam". The FDA issued a decision of Substantially Equivalent on February 18, 2016. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Denali Corporation has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2016
Date Received
July 14, 2015
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 Denali Corporation

  • K153191 — Calcium Bridge (February 26, 2016)
  • K152322 — Resolve 2.0 (December 16, 2015)
  • K141503 — DENALI 501CEMENT (November 10, 2014)
  • K132393 — CERCOM II CEMENT (March 14, 2014)
  • K073101 — AURAVENEER CEMENT (January 17, 2008)
  • K071158 — AURALAY PIT & FISSURE SEALANT (June 5, 2007)
  • K070702 — FUSION RESIN CEMENT AND CORE KIT (May 10, 2007)
  • K070693 — AURAVUE PIT & FISSURE SEALANT (May 9, 2007)

Other clearances for product code EIE

  • K182118 — armor LC (May 3, 2019)
  • 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)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources