510(k) Report

Devices descending from K071055

1 later device reach Opal Prime & Opal Bond/Orthodontic Bracket System, Models 2626, 2625, 2635… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K094006Opal Bond MVUltradent Products, Inc.20100—