FDA Product Code MVL: Cord, Retraction
Leading manufacturers include Inter-Med/Vista Dental Products, Belport Company, Inc., Gingi-Pak and Eastdent Co., Ltd..
36
Total
36
Cleared
144d
Avg days
1998
Since
Growing category -
3 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
153d avg (recent)
FDA 510(k) Cleared Cord, Retraction Devices (Product Code MVL)
36 devices
Cleared
Mar 27, 2026
CyClean Cord
SS GLOBAL
Dental
88d
Cleared
Feb 27, 2026
One-Stop
Mediclus Co., Ltd.
Dental
91d
Cleared
Sep 24, 2025
Retraxil
Kulzer, LLC
Dental
279d
Cleared
Mar 14, 2022
Stasis Gel
Belport Company, Inc., Gingi-Pak
Dental
311d
Cleared
Jan 10, 2022
Gingi-Aid Gel
Belport Company, Inc., Gingi-Pak
Dental
248d
Cleared
Dec 09, 2021
VOCO Retraction Paste
Voco GmbH
Dental
73d
Cleared
Oct 15, 2020
STATSTIX
Centrix Incorporated
Dental
205d
Cleared
Mar 04, 2020
Vista Clear
Inter-Med/Vista Dental Products
Dental
89d
Cleared
Jun 10, 2019
Vista FS, Vista FS Liquid
Inter-Med/Vista Dental Products
Dental
125d
Cleared
May 03, 2018
Smartcord, Smartcord X
Eastdent Co., Ltd.
Dental
338d
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 510(k) Review Time - MVL Product Code
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 →