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510(k) K944683

BRANEMARK SYSTEM 3.3MM FIXTURE by Nobelpharma USA, Inc. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 1995
Date Received
September 22, 1994
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

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  • 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)
  • K961728 — MIRUSCONE 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)

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