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510(k) K051010

SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70 by Septodont — Product Code EJJ

K051010 is an FDA 510(k) premarket notification submitted by Septodont for the device "SECURALLOY, SEPTALLOY NG 50 AND SEPTALLOY NG 70". The FDA issued a decision of Substantially Equivalent on May 2, 2005. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2005
Date Received
April 21, 2005
Clearance Type
Special
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 Septodont

  • K212283 — BioRoot Flow 0.5g, BioRoot Flow 2g (September 16, 2021)
  • K211799 — Biodentine XP 500, Biodentine XP 200 (August 10, 2021)
  • K172839 — ENDOSOLV (February 13, 2018)
  • K140132 — BIODENTINE (June 27, 2014)
  • K093711 — RACEGEL (February 17, 2010)
  • K092251 — BIODENTINE (October 30, 2009)
  • K063634 — RTR SYRINGE (May 11, 2007)
  • K032708 — PLASTALGIN AND PLASTALGIN ORTHO (November 20, 2003)
  • K023976 — ACROSEAL ROOT CANAL OR APICAL SEALER (January 30, 2003)
  • K780003 — ENDOSOLV E (January 20, 1978)

Other clearances for product code EJJ

  • K053114 — SILVERFIL (November 15, 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)
  • 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)
  • K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (October 31, 2000)
  • K991481 — PARAGON (August 11, 1999)

FDA data resources