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510(k) K905303

ABUTMENT GLO by Implant Innovations International, Inc. — Product Code EJR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
November 28, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Agent, Polishing, Abrasive, Oral Cavity
Device Class
Class I
Regulation Number
872.6030
Review Panel
DE
Submission Type

Other clearances by Implant Innovations International, Inc.

  • K935544 — 3I STANDARD THREADED/SELF-TAPPING THREADED IMPLANTS MODIFICATION (March 13, 1995)
  • K932123 — IMPLANT INNOVATION PRE-ANGLED ABUTMENT SYSTEM (May 27, 1994)
  • K911655 — IMPLARETTE (October 21, 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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