Home / 510(k) Clearances / K972607

510(k) K972607

PLATALLOY by Aalba Dent, Inc. — Product Code EJH

K972607 is an FDA 510(k) premarket notification submitted by Aalba Dent, Inc. for the device "PLATALLOY". The FDA issued a decision of Substantially Equivalent on October 10, 1997. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Aalba Dent, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 1997
Date Received
July 11, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alloy, Metal, Base
Device Class
Class II
Regulation Number
872.3710
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)
  • K972533 — VERA SOLDER (September 5, 1997)
  • K972534 — ALFALLOY (September 5, 1997)
  • K972118 — VERA PDN (August 15, 1997)
  • K972532 — AALBA GOLD SOLDER (August 15, 1997)

Other clearances for product code EJH

  • K123929 — BEGOPAL+ (March 14, 2013)
  • K040180 — CONTINUM V (March 4, 2004)
  • K040179 — CONTINUM (March 3, 2004)
  • K033356 — VERASOFT ES (December 30, 2003)
  • K033045 — DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST (December 23, 2003)
  • K032136 — WIROBOND C (September 4, 2003)
  • K031627 — NANO-TICROWN (June 11, 2003)
  • K030632 — PD CASTA-H (May 7, 2003)
  • K030416 — CERACAST-V (April 14, 2003)
  • K030161 — SUPERBOND (March 17, 2003)

FDA data resources