Traxodent
FDA 510(k) K083695 · Premier Dental Products Co.
510(k) numberK083695
Submission
- Device name
- Traxodent
- Applicant
- Premier Dental Products Co.
Plymouth Meeting, PA, US - Received
- December 15, 2008
- Decision date
- April 28, 2009
- 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
| 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 |
|---|---|---|
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | 03/03/2026SE |
| K253513 | MultiMatch Flow Chameleon AntiMicrobial CompositeEBF · Traditional | 11/07/2025SE |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative CompositeEBF · Traditional | 12/06/2022SE |
| K141839 | Premier EtchKLE · Traditional | 11/17/2014SE |
| K132526 | Knit-Pak+MVL · Traditional | 11/26/2013SE |
| K131212 | Premier Ceramic PrimerKLE · Traditional | 08/26/2013SE |
| K062683 | Enamel Pro VarnishLBH · Traditional | 11/21/2006SE |
| K062166 | Enamel ProEJR · Traditional | 11/21/2006SE |
| K061998 | Premier Self-Etching Bond EnhancerKLE · Traditional | 10/04/2006SE |
| K061997 | Premier Self-Etching Enamel SealantEBC · Traditional | 10/04/2006SE |
Questions and answers
When was Traxodent cleared by the FDA?
Traxodent (K083695) received a 510(k) decision of Substantially Equivalent on April 28, 2009, 134 days after the submission was received.
What is the product code of K083695?
The FDA product code is MVL – Cord, Retraction, a Unclassified device.