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510(k) K961728

MIRUSCONE ABUTMENT SYSTEM by Nobelpharma USA, Inc. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1996
Date Received
May 3, 1996
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 Nobelpharma USA, Inc.

  • K984162 — BRANEMARK BONE-ANCHORED HEARING AID (BAHA) SYSTEM FOR PEDIATRIC USE (June 28, 1999)
  • K962403 — NOBLEPHARMA WIDE ACCESSORIES (September 6, 1996)
  • K955713 — NOBELPHARMA BONE ANCHORED HEARING AID (August 9, 1996)
  • K962130 — BRANEMARK SYSTEMS MKII SELK-TAPPING FIXTURE (July 22, 1996)
  • K961736 — 17 ANGULATED ABUTMENT (July 18, 1996)
  • K961737 — CERA ONE ABUTMENT SYSTEM (July 10, 1996)
  • K960639 — ABUTMENT SELECTION KIT (May 14, 1996)
  • K955697 — ABUTMENT RETRIEVAL KIT (January 30, 1996)
  • K955372 — BALL ATTACHMENT SYSTEM (January 23, 1996)
  • K953435 — BRANEMARK RADIOGRAPHIC DEPTH GUAGE (October 3, 1995)

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