Blade-form Endosseous Dental Implant

Device Code: 1354

Product Code(s): NRQ

Definition: Device Made Of A Material Such As Titanium Or Titanium Alloy, That Is Intended To Be Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Prosthetic Devices, Such As Artificial Teeth, In Order To Restore A Patient's C

Device Classification Information

Device Type ID1354
Device NameBlade-form Endosseous Dental Implant
Regulation DescriptionEndosseous Dental Implant.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(k)
CFR Regulation Number872.3640 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeNRQ
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1354
DeviceBlade-form Endosseous Dental Implant
Product CodeNRQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionEndosseous Dental Implant.
CFR Regulation Number872.3640 [🔎]
TPLC Last Update: 2019-04-02 19:52:35

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