Gingival Retraction Kit
The Gingival Retraction Kit (product code NYF) is a Class 1 dental convenience kit containing materials and instruments used to retract gingival tissue during dental procedures such as crown preparation, regulated under 21 CFR 872.4565 within the Dental specialty. As a convenience kit under the May 1997 Convenience Kits Interim Regulatory Guidance, it is under enforcement discretion and does not require a 510(k) if all guidance criteria are met. The device carries no implant or life-sustaining flags.
Basic Information
- Product Code
- NYF
- Device Class
- FDA class 1
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Review Panel
- DE
- 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 https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. 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 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.