FDA · official record K881662Substantially Equivalent for Some Indications

EXPANDED CLAIMES TO OSTEOGEN(R)

Name: EXPANDED CLAIMES TO OSTEOGEN(R) — FDA K881662
Creator: Impladent
Keywords: EXPANDED CLAIMES TO OSTEOGEN(R), EXPANDED CLAIMES TO OSTEOGEN(R), K881662, DZE, FDA

United StatesDZEImpladent

Verified

Official record identity

FDA application number: K881662
Decision date: September 01, 1988
Published decision: Substantially Equivalent for Some Indications

Classification

Product code: DZE

Published parties

Applicant: Impladent

Additional source fields

Decision code: SN
Published decision: Substantially Equivalent for Some Indications
Submission type: Traditional
Received date: 1988-04-15
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.