Colorant
FDA 510(k) K790438 · Vivadent (Usa), Inc.
510(k) numberK790438
Submission
- Device name
- Colorant
- Applicant
- Vivadent (Usa), Inc.
Mchenry, IL, US - Received
- March 7, 1979
- Decision date
- April 10, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254091 | Glossy Coat (15ML)EBD · Traditional | YAMAHACHI DENTAL MFG., Co. | 04/06/2026SE |
| K250804 | Id Light Cure SystemEBD · Traditional | Id Korea Co., Ltd. | 06/04/2025SE |
| K240735 | visio.lign color, visio.lign shieldEBD · Traditional | Bredent GmbH & Co. KG | 12/12/2024SE |
| K223365 | RODIN Palette Naturalizing KitEBD · Traditional | Belport Company, Inc., Gingi-Pak | 03/27/2023SE |
| K211854 | VITA Akzent LCEBD · Traditional | Vita Zahnfabrik GmbH H Rauter & CO | 11/22/2021SE |
| K162408 | Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional | Dreve Dentamid GmbH | 04/05/2018SE |
| K163568 | Shofu Resin GlazeEBD · Traditional | Shofu Dental Corporation | 08/16/2017SE |
| K133836 | Optiglaze ColorEBD · Traditional | GC America, Inc. | 03/06/2014SE |
| K123761 | Vita Enamic StainsEBD · Traditional | Innovation Meditech GmbH | 03/01/2013SE |
| K093019 | Enamelite Acryseal Spray SealantEBD · Traditional | Enamelite, LLC | 12/22/2009SE |
More from Enamelite, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K863831 | Vivadent FilpinEBL · Traditional | 10/14/1986SE |
| K823409 | Heliosit-OrthodonticDYH · Traditional | 01/21/1983SE |
| K813015 | HeliosealEBC · Traditional | 12/02/1981SE |
| K802679 | SilanitEBG · Traditional | 12/17/1980SE |
| K802684 | HeliomatEAY · Traditional | 11/24/1980SE |
| K802683 | HeliositEBF · Traditional | 11/24/1980SE |
| K802682 | Contact SealEBC · Traditional | 11/24/1980SE |
| K802681 | HeliobondKLE · Traditional | 11/24/1980SE |
| K802685 | ReolitEJK · Traditional | 11/12/1980SE |
| K802680 | Isopast-DsEBF · Traditional | 11/12/1980SE |
Questions and answers
When was Colorant cleared by the FDA?
Colorant (K790438) received a 510(k) decision of Substantially Equivalent on April 10, 1979, 34 days after the submission was received.
What is the product code of K790438?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.