FDA · official record K960696Substantially Equivalent

PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM

Name: PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM — FDA K960696
Creator: Ultradent Products, Inc.
Keywords: PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM, PERMALUTE COMPOSITE LUTING/RESTORATIVE RESIN SYSTEM, K960696, KLE, FDA

United StatesKLEUltradent Products, Inc.

Verified

Official record identity

FDA application number: K960696
Decision date: July 18, 1996
Published decision: Substantially Equivalent

Classification

Product code: KLE

Published parties

Applicant: Ultradent Products, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1996-02-20
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3200

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.