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510(k) K833261

INTERIM TEMP. CROWN & BRIDGE RESIN by Coe Laboratories, Inc. — Product Code EBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 1984
Date Received
September 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Crown And Bridge, Temporary, Resin
Device Class
Class II
Regulation Number
872.3770
Review Panel
DE
Submission Type

Other clearances by Coe Laboratories, Inc.

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  • 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)
  • 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)

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