FDA · official record K070184Substantially Equivalent

DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT

Name: DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT — FDA K070184
Creator: Ospol AB
Keywords: DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT, DENTAL IMPLANT, DENTAL ABUTMENT, ABUTMENT SCREW, COVER SCREW, HEALING ABUTMENT, K070184, DZE, FDA

United StatesDZEOspol AB

Verified

Official record identity

FDA application number: K070184
Decision date: March 24, 2008
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Ospol AB

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2007-01-19
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3640

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.