FDA · official record K972553Substantially Equivalent

LANG DENTAL RESIN A97 FIBRED PINK

Name: LANG DENTAL RESIN A97 FIBRED PINK — FDA K972553
Creator: Lang Dental Mfg. Co., Inc.
Keywords: LANG DENTAL RESIN A97 FIBRED PINK, LANG DENTAL RESIN A97 FIBRED PINK, K972553, EBI, FDA

United StatesEBILang Dental Mfg. Co., Inc.

Verified

Official record identity

FDA application number: K972553
Decision date: November 13, 1997
Published decision: Substantially Equivalent

Classification

Product code: EBI

Published parties

Applicant: Lang Dental Mfg. Co., Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1997-07-08
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3760

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.