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510(k) K881422

COE PAK AUTO MIX, REGULAR OR HARD SET by Coe Laboratories, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1988
Date Received
April 5, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cement, Dental
Device Class
Class II
Regulation Number
872.3275
Review Panel
DE
Submission Type

Other clearances by Coe Laboratories, Inc.

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  • K891140 — OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT (May 1, 1989)
  • K885010 — TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING (February 13, 1989)
  • 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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