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510(k) K894282

FIRST IMPRESSION TM by Coe Laboratories, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 1989
Date Received
June 23, 1989
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.

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  • 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)
  • 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)
  • K844326 — OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE (December 3, 1984)

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