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510(k) K945723

OPULENT 76 AND 83 by Aalba Dent, Inc. — Product Code EJT

K945723 is an FDA 510(k) premarket notification submitted by Aalba Dent, Inc. for the device "OPULENT 76 AND 83". The FDA issued a decision of Substantially Equivalent on December 29, 1994. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Aalba Dent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
November 21, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Gold-Based Noble Metal
Device Class
Class II
Regulation Number
872.3060
Review Panel
DE
Submission Type

Other clearances by Aalba Dent, Inc.

  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K982094 — VERABOND 2 (July 22, 1998)
  • K972971 — NPG + 2 (January 5, 1998)
  • K973265 — VERABOND 2V (October 16, 1997)
  • K972607 — PLATALLOY (October 10, 1997)
  • K972533 — VERA SOLDER (September 5, 1997)
  • K972534 — ALFALLOY (September 5, 1997)
  • K972532 — AALBA GOLD SOLDER (August 15, 1997)

Other clearances for product code EJT

  • K052463 — PROMETAL HN86 (October 14, 2005)
  • K041378 — BIO 60 (August 2, 2004)
  • K040672 — PORTA REFLEX (May 27, 2004)
  • K040524 — PORTA SOLDER 1090 W (May 20, 2004)
  • K040043 — NDX-40 ALLOY (March 3, 2004)
  • K034049 — HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, (March 1, 2004)
  • K033279 — GOLD DENTAL CASTING ALLOYS (January 15, 2004)
  • K033446 — APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82 (November 13, 2003)
  • K033435 — E-SARANG 86, DM78, DM55 (November 12, 2003)
  • K032320 — APPOLLO 3 ALLOY (October 1, 2003)

FDA data resources