FDA · official record K002461Substantially Equivalent

HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT

Name: HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT — FDA K002461
Creator: Shofu Dental Corp.
Keywords: HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT, HY-BOND POLYCARBOXYLATE TEMPORARY DENTAL CEMENT, K002461, EMA, FDA

United StatesEMAShofu Dental Corp.

Verified

Official record identity

FDA application number: K002461
Decision date: September 26, 2000
Published decision: Substantially Equivalent

Classification

Product code: EMA

Published parties

Applicant: Shofu Dental Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2000-08-10
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.