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510(k) K021613

NIVEOUS LIQUID DAM by Shofu Dental Corp. — Product Code EIE

K021613 is an FDA 510(k) premarket notification submitted by Shofu Dental Corp. for the device "NIVEOUS LIQUID DAM". The FDA issued a decision of Substantially Equivalent on June 20, 2002. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Shofu Dental Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2002
Date Received
May 16, 2002
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 Shofu Dental Corp.

  • K111855 — HY-BOND RESIGLASS (November 17, 2011)
  • K110252 — BEAUTIBOND MULTI PR PLUS (May 13, 2011)
  • K110235 — BEAUTIBOND MULTI (May 13, 2011)
  • K101621 — LITE ART (August 23, 2010)
  • K101603 — BEAUTIFIL FLOW PLUS (August 23, 2010)
  • K093559 — VINTAGE MP (March 3, 2010)
  • K082744 — BEAUTIBOND (December 11, 2008)
  • K080834 — VINTAGE ART (June 11, 2008)
  • K080517 — RESICEM (June 11, 2008)
  • K080068 — BEAUTIFIL OPAQUER (February 28, 2008)

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)
  • K010935 — BRITESMILE BARRIER MATERIAL (September 5, 2001)
  • K983227 — POWER BLOCK (December 11, 1998)
  • K972775 — FASTDAM (February 27, 1998)

FDA data resources