FDA · official record K813532Substantially Equivalent

CUTTERBOND ZINC PHOSPHATE CEMENT

Name: CUTTERBOND ZINC PHOSPHATE CEMENT — FDA K813532
Creator: Cutter Laboratories, Inc.
Keywords: CUTTERBOND ZINC PHOSPHATE CEMENT, CUTTERBOND ZINC PHOSPHATE CEMENT, K813532, EMA, FDA

United StatesEMACutter Laboratories, Inc.

Verified

Official record identity

FDA application number: K813532
Decision date: March 02, 1982
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Cutter Laboratories, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1981-12-17
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3275

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.