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- Subpart G—Miscellaneous DevicesCFR Sub-Part
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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
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
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]