Home / 510(k) Clearances / K911655

510(k) K911655

IMPLARETTE by Implant Innovations International, Inc. — Product Code EKJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1991
Date Received
April 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Burnisher, Operative
Device Class
Class I
Regulation Number
872.4565
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)
  • 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)

Other clearances for product code EKJ

  • K961714 — ASEPTYLUM, UNI-CARRIER (June 10, 1996)
  • K953707 — MEDTROL DENTAL KIT (January 4, 1996)
  • K945815 — DENTAL KIT (July 19, 1995)
  • K951607 — SUREFLEX FILES (June 22, 1995)
  • K945077 — INSTRUMENT,FILLING,PLASTIC,DENTAL (November 30, 1994)
  • K943820 — STAT PAK (November 2, 1994)
  • K943351 — MAUNAL DISPOSABLE DENTAL INSTRUMENTS (October 7, 1994)
  • K943584 — PRESTERILIZED ENDODONTIC FILES (September 21, 1994)
  • K935127 — SOUTHLAND STERILE DENTAL SYSTEM (July 28, 1994)
  • K941954 — NON-FOGGING DENTAL MIRROR (July 8, 1994)