FDA · official record K853788Substantially Equivalent

DB PRECISION IMPLANT SYSTEM

Name: DB PRECISION IMPLANT SYSTEM — FDA K853788
Creator: Driskell Bioengineering
Keywords: DB PRECISION IMPLANT SYSTEM, DB PRECISION IMPLANT SYSTEM, K853788, DZE, FDA

United StatesDZEDriskell Bioengineering

Verified

Official record identity

FDA application number: K853788
Decision date: October 31, 1985
Published decision: Substantially Equivalent

Classification

Product code: DZE

Published parties

Applicant: Driskell Bioengineering

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1985-09-10
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.