Home / 510(k) Clearances / K052463

510(k) K052463

PROMETAL HN86 by Prometal Technologies — Product Code EJT

K052463 is an FDA 510(k) premarket notification submitted by Prometal Technologies for the device "PROMETAL HN86". The FDA issued a decision of Substantially Equivalent on October 14, 2005. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 14, 2005
Date Received
September 8, 2005
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 for product code EJT

  • 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)
  • K032319 — CERA R PLUS ALLOY (September 30, 2003)

FDA data resources