FDA · official record K992838Substantially Equivalent

ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE

Name: ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE — FDA K992838
Creator: Biomat Sciences, Inc.
Keywords: ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE, ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATE, K992838, KLE, FDA

United StatesKLEBiomat Sciences, Inc.

Verified

Official record identity

FDA application number: K992838
Decision date: November 15, 1999
Published decision: Substantially Equivalent

Classification

Product code: KLE

Published parties

Applicant: Biomat Sciences, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-08-23
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.