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Agent, Polishing, Abrasive, Oral Cavity

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6030
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6030 Oral cavity abrasive polishing agent

§ 872.6030 Oral cavity abrasive polishing agent.

(a) Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

(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 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001]

Agent, Polishing, Abrasive, Oral Cavity

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.6030
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.6030 Oral cavity abrasive polishing agent

§ 872.6030 Oral cavity abrasive polishing agent.

(a) Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

(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 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001]