FDA · official record K940845Substantially Equivalent

SYSTEM 1

Name: SYSTEM 1 — FDA K940845
Creator: Sybron Dental Specialties, Inc.
Keywords: SYSTEM 1, SYSTEM 1, K940845, DYH, FDA

United StatesDYHSybron Dental Specialties, Inc.

Verified

Official record identity

FDA application number: K940845
Decision date: March 31, 1994
Published decision: Substantially Equivalent

Classification

Product code: DYH

Published parties

Applicant: Sybron Dental Specialties, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1994-02-23
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3750

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.