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510(k) K830083

SHUR GEL by Columbus Dental Mfg. Co. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Impression
Device Class
Class II
Regulation Number
872.3660
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)
  • K863816 — IVORY PREMIUM RUBBER DAM (October 27, 1986)
  • K863758 — ORTHO-BITE WAX WAFER (October 7, 1986)
  • K860855 — SHUR GEL 4 (June 16, 1986)

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