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510(k) K872243

PEKALUX(TM) by Columbus Dental Mfg. Co. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 7, 1987
Date Received
June 11, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
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)
  • K871164 — GLUMA(TM) BONDING SYSTEM (July 2, 1987)
  • K872272 — PEKALUX/GLUMA LIGHT CURED ANTERIOR RESTORATIVE SYS (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)
  • K830083 — SHUR GEL (February 7, 1983)

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