Product Code: NRU FDA class 1 21 CFR 872.6250

Chair, Dental, Without Operative Unit

Dental

The Dental Chair Without Operative Unit is a powered device designed to seat a patient in the proper position for performing dental procedures. It provides patient positioning support independent of operative dental equipment. This is an FDA Class 1 device regulated under 21 CFR 872.6250 in the Dental specialty, with product code NRU, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.

510(k)s
0
FEI Numbers
107
Registration Numbers
107
Unique Applicants
0
Years Active

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Basic Information

Product Code
NRU
Device Class
FDA class 1
Regulation Number
872.6250
Medical Specialty
Dental
Review Panel
DE
Submission Type
4

Device Characteristics

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.

FEI Numbers

This FDA classification entry is associated with 107 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 107 registration numbers. Click on an entry to view related FDA registrations.