510(k) K040205

INTRA-LOCK INTERNATIONAL ANGLED PROSTHETIC ABUTMENTS by Intra-Lock International — Product Code NHA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 2004
Date Received
January 30, 2004
Clearance Type
Abbreviated
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.