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510(k) K021045

ERA IMPLANT by Sterngold — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2002
Date Received
April 1, 2002
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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  • K003007 — GALAXY (November 17, 2000)
  • K991436 — STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND I (May 7, 1999)

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