FDA Product Code MVL: Cord, Retraction
Leading manufacturers include Mediclus Co., Ltd., SS GLOBAL and Voco GmbH.
FDA 510(k) Cleared Cord, Retraction Devices (Product Code MVL)
About Product Code MVL - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code MVL since 1998, with 36 receiving FDA clearance (average review time: 144 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for MVL submissions have been consistent, averaging 153 days recently vs 143 days historically.
MVL devices are reviewed by the Dental panel. Browse all Dental devices →