FDA · official record K071055Substantially Equivalent

OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802

Name: OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 — FDA K071055
Creator: Ultradent Products, Inc.
Keywords: OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802, OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802, K071055, DYW, FDA

United StatesDYWUltradent Products, Inc.

Verified

Official record identity

FDA application number: K071055
Decision date: May 03, 2007
Published decision: Substantially Equivalent

Classification

Product code: DYW

Published parties

Applicant: Ultradent Products, Inc.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2007-04-16
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.5470

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.