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Adhesive, Denture, Karaya

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3450
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive

§ 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.

(a) Identification. Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

(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.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000]

Adhesive, Denture, Karaya

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
872.3450
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive

§ 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.

(a) Identification. Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

(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.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000]