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510(k) K881091

OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIAL by Coe Laboratories, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 1988
Date Received
March 8, 1988
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 Coe Laboratories, Inc.

  • K903292 — ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS (October 19, 1990)
  • K894282 — FIRST IMPRESSION TM (December 22, 1989)
  • K894281 — FIRST IMPRESSION WITH CHLORHEXIDINE (September 26, 1989)
  • K891140 — OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT (May 1, 1989)
  • K885010 — TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING (February 13, 1989)
  • K881422 — COE PAK AUTO MIX, REGULAR OR HARD SET (October 31, 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)
  • K844326 — OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE (December 3, 1984)

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