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Chair, Dental, Without Operative Unit

Page Type
Product Code
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.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6250 Dental chair and accessories

§ 872.6250 Dental chair and accessories.

(a) Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.

(b) Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]

Chair, Dental, Without Operative Unit

Page Type
Product Code
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.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6250
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6250 Dental chair and accessories

§ 872.6250 Dental chair and accessories.

(a) Identification. A dental chair and accessories is a device, usually AC-powered, in which a patient sits. The device is intended to properly position a patient to perform dental procedures. A dental operative unit may be attached.

(b) Classification. Class I. The dental chair without the operative unit device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.

[55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994]