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510(k) K023501

GOLD CORE 35 by Pentron Laboratory Technologies — Product Code EJT

K023501 is an FDA 510(k) premarket notification submitted by Pentron Laboratory Technologies for the device "GOLD CORE 35". The FDA issued a decision of Substantially Equivalent on December 18, 2002. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Pentron Laboratory Technologies has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2002
Date Received
October 18, 2002
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 Pentron Laboratory Technologies

  • K023742 — SCULPTURE PLUS NANO-HYBRID COMPOSITE (January 17, 2003)
  • K023499 — GOLD CORE PLUS (January 13, 2003)
  • K023502 — JEWEL CAST PLUS (December 18, 2002)
  • K020555 — SONATA MICRO HYBRID COMPOSITE (April 22, 2002)

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