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510(k) K022224

COOL BOND LIGHT CURED BRACKET ADHESIVE SYSTEM by Coltene AG — Product Code DYH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2002
Date Received
July 10, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adhesive, Bracket And Tooth Conditioner, Resin
Device Class
Class II
Regulation Number
872.3750
Review Panel
DE
Submission Type

Other clearances by Coltene AG

  • K041098 — COOL TEMP NATURAL (May 13, 2004)
  • K902392 — COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL (August 28, 1990)
  • 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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