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510(k) K810907

COLTENE ORALLY by Coltene, Inc. — Product Code EJJ

K810907 is an FDA 510(k) premarket notification submitted by Coltene, Inc. for the device "COLTENE ORALLY". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Coltene, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
April 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Amalgam
Device Class
Class II
Regulation Number
872.3070
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)
  • 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)

Other clearances for product code EJJ

  • K053114 — SILVERFIL (November 15, 2005)
  • K051010 — SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 (May 2, 2005)
  • K033434 — BESTALOY (November 12, 2003)
  • K032152 — BENCO ADMIX (August 6, 2003)
  • K031658 — BENCO SPHERICAL (July 29, 2003)
  • K020452 — HIGH SILVER CONVENTIONAL (May 7, 2002)
  • K011801 — FUTURA TOPCAP NON GAMMA-2 (August 16, 2001)
  • K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (October 31, 2000)
  • K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (October 31, 2000)
  • K002811 — ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (October 31, 2000)

FDA data resources