Retraxil
FDA 510(k) K243910 · Kulzer, LLC
510(k) numberK243910
Submission
- Device name
- Retraxil
- Applicant
- Kulzer, LLC
South Bend, IN, US - Received
- December 19, 2024
- Decision date
- September 24, 2025
- 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 |
| 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 |
| K162662 | GingiDent Gingival Retraction PasteMVL · Traditional | Pac-Dent International, Inc. | 10/20/2017SE |
More from Pac-Dent International, Inc.
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| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…EBF · Traditional | 09/17/2024SE |
| K233868 | dima Print Teeth & TempEBG · Traditional | 05/23/2024SE |
| K230644 | Signum opaque FEBF · Traditional | 09/07/2023SE |
| K220605 | Venus Bulk Flow ONEEBF · Special | 04/21/2022SE |
| K905058 | Palavit LEBH · Traditional | 06/06/1991SE |
| K904928 | Palavit GLCEGD · Traditional | 06/06/1991SE |
| K910263 | CharismaEBF · Traditional | 06/03/1991SE |
| K910719 | Silicoater MDEMA · Traditional | 04/29/1991SE |
Questions and answers
When was Retraxil cleared by the FDA?
Retraxil (K243910) received a 510(k) decision of Substantially Equivalent on September 24, 2025, 279 days after the submission was received.
What is the product code of K243910?
The FDA product code is MVL – Cord, Retraction, a Unclassified device.