Home / 510(k) Clearances / K023499

510(k) K023499

GOLD CORE PLUS by Pentron Laboratory Technologies — Product Code EJH

K023499 is an FDA 510(k) premarket notification submitted by Pentron Laboratory Technologies for the device "GOLD CORE PLUS". The FDA issued a decision of Substantially Equivalent on January 13, 2003. The device falls under product code EJH (Alloy, Metal, Base), a Class II device regulated under 21 CFR 872.3710. Pentron Laboratory Technologies has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2003
Date Received
October 18, 2002
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 Pentron Laboratory Technologies

  • K023742 — SCULPTURE PLUS NANO-HYBRID COMPOSITE (January 17, 2003)
  • K023502 — JEWEL CAST PLUS (December 18, 2002)
  • K023501 — GOLD CORE 35 (December 18, 2002)
  • K020555 — SONATA MICRO HYBRID COMPOSITE (April 22, 2002)

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