Gingi-Aid Gel
FDA 510(k) K211419 · Belport Company, Inc., Gingi-Pak
510(k) numberK211419
Submission
- Device name
- Gingi-Aid Gel
- Applicant
- Belport Company, Inc., Gingi-Pak
Camarillo, CA, US - Received
- May 7, 2021
- Decision date
- January 10, 2022
- 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
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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 |
| 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 |
| K162662 | GingiDent Gingival Retraction PasteMVL · Traditional | Pac-Dent International, Inc. | 10/20/2017SE |
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| K223365 | RODIN Palette Naturalizing KitEBD · Traditional | 03/27/2023SE |
| K211420 | Stasis GelMVL · Traditional | 03/14/2022SE |
| K200462 | EtchPro Etching GelKLE · Traditional | 09/02/2020SE |
Questions and answers
When was Gingi-Aid Gel cleared by the FDA?
Gingi-Aid Gel (K211419) received a 510(k) decision of Substantially Equivalent on January 10, 2022, 248 days after the submission was received.
What is the product code of K211419?
The FDA product code is MVL – Cord, Retraction, a Unclassified device.