FDA · official record K944981Substantially Equivalent

3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM

Name: 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM — FDA K944981
Creator: 3M Company
Keywords: 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM, 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM, K944981, EBG, FDA

United StatesEBG3M Company

Verified

Official record identity

FDA application number: K944981
Decision date: December 02, 1994
Published decision: Substantially Equivalent

Classification

Product code: EBG

Published parties

Applicant: 3M Company

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1994-10-07
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.3770

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.