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510(k) K925349

ONE SYSTEM TAPERED TITANIUM ABUTMENTS by Implant Support Systems, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 1993
Date Received
October 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abutment, Implant, Dental, Endosseous
Device Class
Class II
Regulation Number
872.3630
Review Panel
DE
Submission Type

To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.

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)
  • 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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