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Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

Page Type
Product Code
Definition
OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3540
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3540 OTC denture cushion or pad

§ 872.3540 OTC denture cushion or pad.

(a) Identification. An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter.

(b) Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The device is intended to be discarded following 1 day's use. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.

(2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. 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. The special controls for this device are FDA's:

(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical - Devices Part I: Evaluation and Testing,’ ” and

(ii) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2315, 2000; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]

Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter

Page Type
Product Code
Definition
OTC denture cushion or pad made of wax impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The Device is intended to be discarded following 1 day's use.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3540
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3540 OTC denture cushion or pad

§ 872.3540 OTC denture cushion or pad.

(a) Identification. An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter.

(b) Classification. (1) Class I if the device is made of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The device is intended to be discarded following 1 day's use. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.

(2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in paragraph (b)(1) of this section. 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. The special controls for this device are FDA's:

(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical - Devices Part I: Evaluation and Testing,’ ” and

(ii) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2315, 2000; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]