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510(k) K072730

FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS by Dentsply Intl. — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2008
Date Received
September 26, 2007
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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  • K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (October 30, 2009)
  • K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM (May 22, 2009)
  • K082198 — DURASHIELD PLUS (October 29, 2008)
  • K072989 — AXIS SYSTEM (January 28, 2008)
  • K073117 — DENTIN DESENSITIZER AGENT (December 19, 2007)
  • K070538 — XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE (March 14, 2007)

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