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510(k) K863816

IVORY PREMIUM RUBBER DAM by Columbus Dental Mfg. Co. — Product Code EIE

K863816 is an FDA 510(k) premarket notification submitted by Columbus Dental Mfg. Co. for the device "IVORY PREMIUM RUBBER DAM". The FDA issued a decision of Substantially Equivalent on October 27, 1986. The device falls under product code EIE (Dam, Rubber), a Class I device regulated under 21 CFR 872.6300. Columbus Dental Mfg. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1986
Date Received
September 30, 1986
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 Columbus Dental Mfg. Co.

  • K880754 — DRI-CLAVE LIQUID KLEENZALL (May 12, 1988)
  • K880607 — UTILITY WAX STRIPS, SPEARMINT (March 31, 1988)
  • K880606 — UTILITY WAX STRIPS, CINNAMON (March 24, 1988)
  • K872243 — PEKALUX(TM) (July 7, 1987)
  • K872272 — PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS (July 2, 1987)
  • K871164 — GLUMA(TM) BONDING SYSTEM (July 2, 1987)
  • K871165 — LUMIFOR(TM) COMPOSITE (April 3, 1987)
  • K863758 — ORTHO-BITE WAX WAFER (October 7, 1986)
  • K860855 — SHUR GEL 4 (June 16, 1986)
  • K830083 — SHUR GEL (February 7, 1983)

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