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510(k) K954990

DENTAL DAM by The Hygenic Corp. — Product Code EIE

K954990 is an FDA 510(k) premarket notification submitted by The Hygenic Corp. for the device "DENTAL DAM". The FDA issued a decision of Substantially Equivalent on January 26, 1996. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. The Hygenic Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1996
Date Received
October 31, 1995
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 The Hygenic Corp.

  • K930764 — ENDO-ICE-PULP TESTER-THERMAL (May 27, 1993)
  • K905418 — GATES GLIDDEN DRILLS (July 25, 1991)
  • K911225 — TRAY DOUGH (April 17, 1991)
  • K905640 — SOLID CORE GUTTA PERCHA CARRIER (March 5, 1991)
  • K900301 — NOVUS BONDING AGENT (May 15, 1990)
  • K900844 — WEDJETS (April 16, 1990)
  • K894092 — DENTAL ENDODONTIC CEMENT (MODIFICATION) (January 10, 1990)
  • K881826 — ENDO-ICE (August 23, 1988)
  • K873644 — PULP PEN (October 27, 1987)
  • K863393 — ENDOCATER (June 11, 1987)

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