FDA · official record K002991Substantially Equivalent

ZAP DUAL CURING LIGHT

Name: ZAP DUAL CURING LIGHT — FDA K002991
Creator: Soft-Core Texas, Inc.
Keywords: ZAP DUAL CURING LIGHT, ZAP DUAL CURING LIGHT, K002991, EBZ, FDA

United StatesEBZSoft-Core Texas, Inc.

Verified

Official record identity

FDA application number: K002991
Decision date: November 28, 2000
Published decision: Substantially Equivalent

Classification

Product code: EBZ

Published parties

Applicant: Soft-Core Texas, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2000-09-25
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.6070

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.