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510(k) K892239

DENTAL HAND INSTRUMENTS by Implant Support Systems, Inc. — Product Code EKJ

K892239 is an FDA 510(k) premarket notification submitted by Implant Support Systems, Inc. for the device "DENTAL HAND INSTRUMENTS". The FDA issued a decision of Substantially Equivalent on May 18, 1989. The device falls under product code EKJ (Burnisher, Operative), a Class I device regulated under 21 CFR 872.4565. Implant Support Systems, Inc. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 1989
Date Received
February 23, 1989
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 Support Systems, Inc.

  • K933532 — SELF TAPPING DENTAL IMPLANT SYSTEM (September 21, 1994)
  • K924589 — RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (June 22, 1994)
  • K925312 — HAND INSTRUMENT CALCULUS REMOVAL (May 23, 1994)
  • K925313 — TITANIUM COC ABUTMENT HEADS FOR IMZ (July 30, 1993)
  • K925349 — ONE SYSTEM TAPERED TITANIUM ABUTMENTS (July 27, 1993)
  • K924190 — ISS O-RING ATTACHMENT (May 27, 1993)
  • K921764 — DALLA BONA BALL & SOCKEY ATTACH. SNAP TYPE PRECIS (November 3, 1992)
  • K904605 — TITANIUM COC ABUTMENT HEADS FOR IMZ (January 29, 1991)
  • K895986 — PRECISION DENTAL ATTACHMENTS (October 18, 1989)

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)

FDA data resources