MVL

FDA Product Code MVL: Cord, Retraction

Leading manufacturers include Ultradent Products, Inc., Centrix, Inc. and Belport Company, Inc., Gingi-Pak.

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
1–24 of 36
Cleared Mar 27, 2026
CyClean Cord
K254239
SS GLOBAL
Dental · 88d
Cleared Feb 27, 2026
One-Stop
K253797
Mediclus Co., Ltd.
Dental · 91d
Cleared Sep 24, 2025
Retraxil
K243910
Kulzer, LLC
Dental · 279d
Cleared Mar 14, 2022
Stasis Gel
K211420
Belport Company, Inc., Gingi-Pak
Dental · 311d
Cleared Jan 10, 2022
Gingi-Aid Gel
K211419
Belport Company, Inc., Gingi-Pak
Dental · 248d
Cleared Dec 09, 2021
VOCO Retraction Paste
K213149
Voco GmbH
Dental · 73d
Cleared Oct 15, 2020
STATSTIX
K200764
Centrix Incorporated
Dental · 205d
Cleared Mar 04, 2020
Vista Clear
K193389
Inter-Med/Vista Dental Products
Dental · 89d
Cleared Jun 10, 2019
Vista FS, Vista FS Liquid
K190220
Inter-Med/Vista Dental Products
Dental · 125d
Cleared May 03, 2018
Smartcord, Smartcord X
K171577
Eastdent Co., Ltd.
Dental · 338d
Cleared Sep 24, 2015
Astringedent Clear
K152064
Ultradent Products, Inc.
Dental · 62d
Cleared Nov 26, 2013
KNIT-PAK+
K132526
Premier Dental Products Co.
Dental · 106d
Cleared Feb 05, 2013
VISCOSTAT CLEAR
K123215
Ultradent Products, Inc.
Dental · 113d
Cleared Apr 12, 2012
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K113839
Parkell, Inc.
Dental · 106d
Cleared Jul 22, 2011
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K111348
Centrix, Inc.
Dental · 70d
Cleared Nov 04, 2009
LIQUICORD
K092384
Centrix, Inc.
Dental · 91d
Cleared Jul 30, 2009
CORDCAP
K091380
Centrix, Inc.
Dental · 80d
Cleared Apr 28, 2009
TRAXODENT
K083695
Premier Dental Products Co.
Dental · 134d
Cleared Mar 15, 2001
ULTRAPAK NEHA
K010070
Ultradent Products, Inc.
Dental · 66d
Cleared Jul 31, 1998
ULTRAPAK E
K981596
Ultradent Products, Inc.
Dental · 88d

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 →