3 results
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6ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Iii
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INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
FDA Enforcement
Class III
·Terminated·Carestream Health Inc.·August 13, 2014
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels --- Carestream Health Inc.
FDA Enforcement
Class III
·Terminated·Carestream Health Inc.·August 13, 2014
The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.
FDA Enforcement
Class III
·Terminated·Ormco/Sybronendo·October 31, 2012