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510(k) K982671

SECURALLOY by Specialites Septodont — Product Code EJJ

K982671 is an FDA 510(k) premarket notification submitted by Specialites Septodont for the device "SECURALLOY". The FDA issued a decision of Substantially Equivalent on October 19, 1998. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Specialites Septodont has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 1998
Date Received
July 31, 1998
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 Specialites Septodont

  • K012427 — PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT (October 9, 2001)
  • K010415 — ISODAN (July 23, 2001)
  • K982773 — QUICKSET LIQUID AND POWDER (November 3, 1998)
  • K980633 — ENDOSOLV E (May 1, 1998)
  • K920692 — SEPTOCALCINE ULTRA (April 21, 1992)
  • K915466 — SEPTOPACK TEMPORARY FILLING (February 3, 1992)
  • K915467 — CIMPAT S DENTAL CEMENT (February 3, 1992)
  • K913573 — SAFETY PLUS DENTAL INJECTION NEEDLE (November 7, 1991)
  • K913572 — AUTOPACK NON-EUGENOL PERIODONTAL DRESSING (October 9, 1991)
  • K913574 — SEPTOCAL CAVITY LINER (September 30, 1991)

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)
  • K002811 — ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOY (October 31, 2000)
  • K002808 — ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY (October 31, 2000)
  • K002810 — ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY (October 31, 2000)

FDA data resources