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510(k) K780997

AMALGAM ALLOY by Syntex Corp. — Product Code EJJ

K780997 is an FDA 510(k) premarket notification submitted by Syntex Corp. for the device "AMALGAM ALLOY". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code EJJ (Alloy, Amalgam), a Class II device regulated under 21 CFR 872.3070. Syntex Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1978
Date Received
June 14, 1978
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 Syntex Corp.

  • K920314 — TXIT D.A.U. BARBITURATE ASSAY (MODIFICATION) (April 17, 1992)
  • K843593 — SURGIPRESS SURGICAL LOOP (October 24, 1984)
  • K780769 — S-100 CT SCANNER (June 2, 1978)
  • K780483 — FIBER OPTIC HANDPIECE (April 28, 1978)
  • K761331 — OPUS I OPTION - FIBER OPTIC L SYSTEM (January 3, 1977)
  • K761332 — HI-SENSITIVITY MODE OPTION FOR S60-1A (December 30, 1976)
  • K761330 — SYNTEX SYSTEM 6000 (December 30, 1976)
  • K761264 — OPTIONS FOR STAR DENTAL OPUS I (December 23, 1976)
  • K761033 — COMPUTERIZED TOMOGRAPHY SCANNER (November 24, 1976)

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