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510(k) K792428

COE-SIL by Coe Laboratories, Inc. — Product Code LDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 1980
Date Received
November 27, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Earmold, Impression
Device Class
Class I
Regulation Number
874.3300
Review Panel
EN
Submission Type

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  • K885010 — TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING (February 13, 1989)
  • K881422 — COE PAK AUTO MIX, REGULAR OR HARD SET (October 31, 1988)
  • K881091 — OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL (June 28, 1988)
  • K863882 — OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITE (November 18, 1986)
  • K842877 — ABSOLUTE VINYL POLYSILOXANE IMPRESS (March 11, 1985)
  • K844325 — COE-LITE POLYMERIZATION UNIT (December 11, 1984)

Other clearances for product code LDG

  • K823921 — PHYSICIANS CHOICE SILICONE EAR PUTTY (March 28, 1983)