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510(k) K935544

3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION by Implant Innovations International, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1995
Date Received
November 12, 1993
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 Implant Innovations International, Inc.

  • K932123 — IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM (May 27, 1994)
  • K911655 — IMPLARETTE (October 21, 1991)
  • K905303 — ABUTMENT GLO (June 10, 1991)
  • K911701 — G-FLOSS & G-FLOSS II (May 15, 1991)
  • K891613 — OVERDENTURE ATTACHMENT (October 10, 1989)
  • K891612 — DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA. (June 12, 1989)
  • K891617 — INSERTION TOOLS (May 1, 1989)
  • K891615 — SURGICAL DRILLS (April 17, 1989)
  • K891618 — TITANIUM FORCEPS (April 17, 1989)
  • K874590 — INNOVATIVE IMPLANTS AND COVER SCREWS (May 11, 1988)

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