Smartcord, Smartcord X
FDA 510(k) K171577 · Eastdent Co., Ltd.
510(k) numberK171577
Submission
- Device name
- Smartcord, Smartcord X
- Applicant
- Eastdent Co., Ltd.
Yongin-Si, KR - Received
- May 30, 2017
- Decision date
- May 3, 2018
- 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 |
| K162662 | GingiDent Gingival Retraction PasteMVL · Traditional | Pac-Dent International, Inc. | 10/20/2017SE |
Questions and answers
When was Smartcord, Smartcord X cleared by the FDA?
Smartcord, Smartcord X (K171577) received a 510(k) decision of Substantially Equivalent on May 3, 2018, 338 days after the submission was received.
What is the product code of K171577?
The FDA product code is MVL – Cord, Retraction, a Unclassified device.