FDA · official record K954790Substantially Equivalent

PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS

Name: PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS — FDA K954790
Creator: Tulsa Dental Products, Ltd.
Keywords: PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS, PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS, K954790, DZA, FDA

United StatesDZATulsa Dental Products, Ltd.

Verified

Official record identity

FDA application number: K954790
Decision date: January 16, 1996
Published decision: Substantially Equivalent

Classification

Product code: DZA

Published parties

Applicant: Tulsa Dental Products, Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 1995-10-19
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.4130

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.