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510(k) K041271

STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM by Sterngold — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2004
Date Received
May 12, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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  • 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)
  • K003007 — GALAXY (November 17, 2000)
  • K991436 — STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND I (May 7, 1999)

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