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 Type ID | 1355 |
Device Name | Chair, Dental, Without Operative Unit |
Regulation Description | Dental Chair And Accessories. |
Regulation Medical Specialty | Dental |
Review Panel | Dental |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 872.6250 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | NRU |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1355 |
Device | Chair, Dental, Without Operative Unit |
Product Code | NRU |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Dental Chair And Accessories. |
CFR Regulation Number | 872.6250 [🔎] |
Device Problems | |
---|---|
Electrical /Electronic Property Problem | 1 |
Total Device Problems | 1 |