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510(k) K925312

HAND INSTRUMENT CALCULUS REMOVAL by Implant Support Systems, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 23, 1994
Date Received
October 21, 1992
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 Support Systems, Inc.

  • K933532 — SELF TAPPING DENTAL IMPLANT SYSTEM (September 21, 1994)
  • K924589 — RESTORE SELF TAPPING DENTAL IMPLANT SYSTEM (June 22, 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)
  • K892239 — DENTAL HAND INSTRUMENTS (May 18, 1989)

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