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510(k) K003007

GALAXY by Sterngold — Product Code EJT

K003007 is an FDA 510(k) premarket notification submitted by Sterngold for the device "GALAXY". The FDA issued a decision of Substantially Equivalent on November 17, 2000. The device falls under product code EJT (Alloy, Gold-Based Noble Metal), a Class II device regulated under 21 CFR 872.3060. Sterngold has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2000
Date Received
September 26, 2000
Clearance Type
Abbreviated
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 Sterngold

  • K092434 — STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM (November 10, 2009)
  • K041271 — STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM (October 28, 2004)
  • K023580 — STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM (January 17, 2003)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K021741 — CRITERTION, MODEL #1067511 (June 26, 2002)
  • K021045 — ERA IMPLANT (June 26, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020949 — APOLLO, MODEL 1124525 (April 4, 2002)
  • K020391 — STERN MICRO ERA ATTACHMENT SYSTEM (March 8, 2002)
  • K991436 — STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND I (May 7, 1999)

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