EBO · Class II · 21 CFR 872.3570

FDA Product Code EBO: Denture Repair Kit

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.

7
Total
7
Cleared
112d
Avg days
1977
Since

FDA 510(k) Cleared Denture Repair Kit Devices (Product Code EBO)

7 devices
1–7 of 7
No devices found for this product code.

About Product Code EBO - Regulatory Context