FDA · official record K820104Substantially Equivalent

NUPRO* GEL TRAY

Name: NUPRO* GEL TRAY — FDA K820104
Creator: Johnson & Johnson Professionals, Inc.
Keywords: NUPRO* GEL TRAY, NUPRO* GEL TRAY, K820104, KMT, FDA

United StatesKMTJohnson & Johnson Professionals, Inc.

Verified

Official record identity

FDA application number: K820104
Decision date: February 23, 1982
Published decision: Substantially Equivalent

Classification

Product code: KMT

Published parties

Applicant: Johnson & Johnson Professionals, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1982-01-15
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6870

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.