FDA · official record K854168Substantially Equivalent

TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES

Name: TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES — FDA K854168
Creator: Travenol Laboratories, S.A.
Keywords: TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES, TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES, K854168, ELA, FDA

United StatesELATravenol Laboratories, S.A.

Verified

Official record identity

FDA application number: K854168
Decision date: March 13, 1986
Published decision: Substantially Equivalent

Classification

Product code: ELA

Published parties

Applicant: Travenol Laboratories, S.A.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1985-10-15
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4565

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.