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510(k) K052885

ZYGOMA 17 ABUTMENT MULTI-UNIT RP 2MM, MODEL 29314; ZYGOMA 17 ABUTMENT MULTI-UNIT RP 3MM, MODEL 29315 by Nobel Biocare USA, LLC — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2005
Date Received
October 13, 2005
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.

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  • K062566 — NOBELREPLACE TAPERED CONICAL CONNECTION (December 6, 2006)
  • K050641 — ZYGOMA TIUNITE (April 7, 2005)
  • K043312 — NOBELRONDO DENTAL CERAMIC - ZIRCONIA (February 1, 2005)

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