Last synced on 2 December 2022 at 11:04 pm

Oral Lubricant

Page Type
Product Code
Definition
An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.
Physical State
viscous liquid or gel
Technical Method
direct application
Target Area
oral hard and soft tissue
Regulation Medical Specialty
General Hospital
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
880.6375
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 880.6375 Patient lubricant

§ 880.6375 Patient lubricant.

(a) Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

(b) Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019]

Oral Lubricant

Page Type
Product Code
Definition
An oral lubricant to be used adjacent to hard and soft tissue and the lips to prevent adherence of dental cement; Placement of a rubber dam; And to prevent the lips from drying and cracking during dental procedures.
Physical State
viscous liquid or gel
Technical Method
direct application
Target Area
oral hard and soft tissue
Regulation Medical Specialty
General Hospital
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 1
Regulation Number
880.6375
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 880.6375 Patient lubricant

§ 880.6375 Patient lubricant.

(a) Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

(b) Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

[45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001; 84 FR 71815, Dec. 30, 2019]