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510(k) K984297

MAGNA ABUTMENT by Factor, Ii, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2000
Date Received
December 1, 1998
Clearance Type
Traditional
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

Other clearances by Factor, Ii, Inc.

  • K880329 — FACTOR II PROSTHETIC SILICONE ELASTOMER (June 1, 1988)
  • K831095 — ROYALE II (August 31, 1983)

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