Retraction Paste
FDA 510(k) K130580 · Dmg USA, Inc.
510(k) numberK130580
Submission
- Device name
- Retraction Paste
- Applicant
- Dmg USA, Inc.
Ayer, MA, US - Received
- March 5, 2013
- Decision date
- February 25, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVL – Cord, Retraction
- Device class
- Unclassified
Other 510(k)s with product code MVL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254239 | CyClean CordMVL · Traditional | SS Global | 03/27/2026SE |
| K253797 | One-StopMVL · Traditional | Mediclus Co., Ltd. | 02/27/2026SE |
| K243910 | RetraxilMVL · Traditional | Kulzer, LLC | 09/24/2025SE |
| K211420 | Stasis GelMVL · Traditional | Belport Company, Inc., Gingi-Pak | 03/14/2022SE |
| K211419 | Gingi-Aid GelMVL · Traditional | Belport Company, Inc., Gingi-Pak | 01/10/2022SE |
| K213149 | VOCO Retraction PasteMVL · Traditional | Voco GmbH | 12/09/2021SE |
| K200764 | StatstixMVL · Traditional | Centrix Incorporated | 10/15/2020SE |
| K193389 | Vista ClearMVL · Traditional | Inter-Med/Vista Dental Products | 03/04/2020SE |
| K190220 | Vista FS, Vista FS LiquidMVL · Traditional | Inter-Med/Vista Dental Products | 06/10/2019SE |
| K171577 | Smartcord, Smartcord XMVL · Traditional | Eastdent Co., Ltd. | 05/03/2018SE |
More from Eastdent Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K171772 | Ecosite Bulk FillEBF · Traditional | 01/31/2018SE |
| K160443 | TempoCem ClearEMA · Traditional | 09/30/2016SE |
| K110759 | TempocemEMB · Abbreviated | 06/10/2011SE |
| K102603 | SA Flowable AdhesiveEBF · Abbreviated | 11/17/2010SE |
| K101710 | Luxatemp Ultra /StarEBG · Abbreviated | 09/28/2010SE |
| K100062 | Infiltration KitEBC · Abbreviated | 03/26/2010SE |
| K093338 | Self Adhesive Composite Luting CementEMA · Abbreviated | 02/12/2010SE |
| K093587 | Dental MercuryELY · Traditional | 01/21/2010SE |
| K081493 | Infiltration KitEBC · Abbreviated | 09/18/2008SE |
| K080480 | Nanocomposite Restorative KitEBF · Abbreviated | 05/30/2008SE |
Questions and answers
When was Retraction Paste cleared by the FDA?
Retraction Paste (K130580) received a 510(k) decision of Substantially Equivalent on February 25, 2014, 357 days after the submission was received.
What is the product code of K130580?
The FDA product code is MVL – Cord, Retraction, a Unclassified device.