FDA · official record K813378Substantially Equivalent

UNI-BITE DENTAL X-RAY FILM HOLDER

Name: UNI-BITE DENTAL X-RAY FILM HOLDER — FDA K813378
Creator: Rinn Corp.
Keywords: UNI-BITE DENTAL X-RAY FILM HOLDER, UNI-BITE DENTAL X-RAY FILM HOLDER, K813378, EGZ, FDA

United StatesEGZRinn Corp.

Verified

Official record identity

FDA application number: K813378
Decision date: January 29, 1982
Published decision: Substantially Equivalent

Classification

Product code: EGZ

Published parties

Applicant: Rinn Corp.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1981-12-01
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.1905

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.