Chair, Dental, Without Operative Unit

Device Code: 1355

Product Code(s): NRU

Definition: A Dental Chair Is A Device, Usually Powered, That Is Intended To Seat A Patient In The Proper Position To Perform A Dental Procedure.

Device Classification Information

Device Type ID1355
Device NameChair, Dental, Without Operative Unit
Regulation DescriptionDental Chair And Accessories.
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) Exempt
CFR Regulation Number872.6250 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNRU
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1355
DeviceChair, Dental, Without Operative Unit
Product CodeNRU
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionDental Chair And Accessories.
CFR Regulation Number872.6250 [🔎]
Device Problems
Electrical /Electronic Property Problem
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 19:52:36

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