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510(k) K882800

COLTENE PRESIDENT JET REGULAR BODY by Coltene, Inc. — Product Code ELW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1988
Date Received
July 7, 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 Coltene, Inc.

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  • K873671 — COLTENE PRESIDENT JET IMPRESSION MATERIALS SYSTEM (October 27, 1987)
  • K870266 — COLTENE BRILLIANT D.I. DIRECT INLAY SYSTEM (February 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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