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510(k) K902392

COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL by Coltene, Inc. — Product Code EMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1990
Date Received
May 30, 1990
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 Coltene, Inc.

  • K041098 — COOL TEMP NATURAL (May 13, 2004)
  • K022224 — COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM (September 18, 2002)
  • K882800 — COLTENE PRESIDENT JET REGULAR BODY (September 23, 1988)
  • 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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