Re / Stasis (TM) Gingival Retraction Paste
FDA 510(k) K111348 · Centrix, Inc.
510(k) numberK111348
Submission
- Device name
- Re / Stasis (TM) Gingival Retraction Paste
- Applicant
- Centrix, Inc.
Shelton, CT, US - Received
- May 13, 2011
- Decision date
- July 22, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MVL – Cord, Retraction
- Device class
- Unclassified
Other 510(k)s with product code MVL
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|---|---|---|---|
| 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 |
|---|---|---|
| K250714 | FluoroDose VarnishLBH · Traditional | 11/21/2025SE |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38%PHR · Traditional | 10/27/2023SE |
| K200764 | StatstixMVL · Traditional | 10/15/2020SE |
| K152826 | NoCordELW · Traditional | 05/27/2016SE |
| K140144 | Benda WedgeEJB · Traditional | 07/08/2014SE |
| K120176 | Senzzzzz AwayLBH · Traditional | 07/25/2012SE |
| K092384 | LiquicordMVL · Traditional | 11/04/2009SE |
| K091380 | CordcapMVL · Traditional | 07/30/2009SE |
| K021131 | ChloraprepLBH · Traditional | 09/26/2002SE |
| K021146 | D/Sense 1-STEPEJK · Traditional | 07/02/2002SE |
Questions and answers
When was Re / Stasis (TM) Gingival Retraction Paste cleared by the FDA?
Re / Stasis (TM) Gingival Retraction Paste (K111348) received a 510(k) decision of Substantially Equivalent on July 22, 2011, 70 days after the submission was received.
What is the product code of K111348?
The FDA product code is MVL – Cord, Retraction, a Unclassified device.