3M Clarity Ultra Self-Ligating Brackets And Adhesive Coated Appliance System

Bracket, Ceramic, Orthodontic

3M Health Care

The following data is part of a premarket notification filed by 3m Health Care with the FDA for 3m Clarity Ultra Self-ligating Brackets And Adhesive Coated Appliance System.

Pre-market Notification Details

Device IDK180404
510k NumberK180404
Device Name:3M Clarity Ultra Self-Ligating Brackets And Adhesive Coated Appliance System
ClassificationBracket, Ceramic, Orthodontic
Applicant 3M Health Care 2510 Conway Avenue St. Paul,  MN  55144 -1000
ContactLam Duong
CorrespondentMark Job
REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul,  MN  55114
Product CodeNJM  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2018-02-14
Decision Date2018-03-16
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.