Oral Irrigation Kit
The Oral Irrigation Kit is a convenience kit providing components for irrigating the oral cavity, used for dental hygiene, post-surgical wound care, or periodontal treatment. Classified as FDA Class 1 under regulation 21 CFR 872.6510 within the Dental medical specialty, it is subject to general controls only and falls under enforcement discretion per the FDA's May 1997 Convenience Kits Interim Regulatory Guidance, exempting it from 510(k) requirements when all criteria are met. The product code is OGT. It is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- OGT
- Device Class
- FDA class 1
- Regulation Number
- 872.6510
- Medical Specialty
- Dental
- Review Panel
- EN
- Submission Type
- 7
Device Characteristics
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.