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Aligner, Beam, X-Ray

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.1820
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.1820 Dental x-ray exposure alignment device

§ 872.1820 Dental x-ray exposure alignment device.

(a) Identification. A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the x-ray beam.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001]

Aligner, Beam, X-Ray

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.1820
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.1820 Dental x-ray exposure alignment device

§ 872.1820 Dental x-ray exposure alignment device.

(a) Identification. A dental x-ray exposure alignment device is a device intended to position x-ray film and to align the examination site with the x-ray beam.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001]