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510(k) K870266

COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM by Coltene, Inc. — Product Code EBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1987
Date Received
January 23, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Material, Tooth Shade, Resin
Device Class
Class II
Regulation Number
872.3690
Review Panel
DE
Submission Type

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  • K882800 — COLTENE PRESIDENT JET REGULAR BODY (September 23, 1988)
  • K873671 — COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM (October 27, 1987)
  • K870047 — COLTENE RAPID (January 29, 1987)
  • K863998 — COLTENE JET-MIXER (October 30, 1986)
  • K850036 — COLTENE PRECISE (February 8, 1985)
  • K840297 — COLTENE ORALLOY MAGICAPS (March 16, 1984)
  • K811666 — COLTENE COLTEX/COLTOFLAX (July 15, 1981)

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