FDA · official record K994368Substantially Equivalent

AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS

Name: AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS — FDA K994368
Creator: American Dental Products, Inc.
Keywords: AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS, AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS, K994368, LFC, FDA

United StatesLFCAmerican Dental Products, Inc.

Verified

Official record identity

FDA application number: K994368
Decision date: March 14, 2000
Published decision: Substantially Equivalent

Classification

Product code: LFC

Published parties

Applicant: American Dental Products, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1999-12-27
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1740

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.