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510(k) K112795

PALTOP DENTAL IMPLANT SYSTEM by Paltop Advanced Dental Solutions, Ltd. — Product Code DZE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2012
Date Received
September 26, 2011
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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  • K130462 — PALTOP NARROW IMPLANT, PALTOP SHORT IMPLANT (August 27, 2013)
  • K131451 — PALTOP DENTAL IMPLANT - STERILE ACCESSORIES (August 22, 2013)

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