ClearanceBrief
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Dental devices

281 product codes reviewed by the Dental panel. 12,700 510(k) clearances and 1,349 recalls in the FDA data, 62% of those recalls name a 510(k).

222510(k)s in 12 months
32recalls in 12 months
832recalls that name a 510(k)

Active product codes, Class I

CodeDeviceClass510(k)s, 12 moRecalls, 12 mo
NSBPatient Personal Hygiene Kit105
OFXGeneral Purpose Dental Tray105
EFBHandpiece, Air-Powered, Dental140
EBWController, Foot, Handpiece And Cord130
EIAUnit, Operative Dental120
JEQToothbrush, Powered102
EFDAmalgamator, Dental, Ac-Powered101
EFWToothbrush, Manual101
EHJDisk, Abrasive101
EKXHandpiece, Direct Drive, Ac-Powered110
NDPAccessories, Implant, Dental, Endosseous101
NYLHandpiece, Air-Powered, Root Canal Irrigation110
QJJIndirect Bonding Tray101
SJHPortable Dental Operative Unit110

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