Shofu Resin Glaze
FDA 510(k) K163568 · Shofu Dental Corporation
510(k) numberK163568
Submission
- Device name
- Shofu Resin Glaze
- Applicant
- Shofu Dental Corporation
San Marcos, CA, US - Received
- December 19, 2016
- Decision date
- August 16, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K082285 | Easy GlazeEBD · Traditional | Voco GmbH | 10/24/2008SE |
More from Voco GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K252808 | GlasIonomer FX-LCEMA · Traditional | 12/09/2025SE |
| K252165 | Zirconomer PEMA · Traditional | 10/28/2025SE |
| K251470 | ResiCem EXEMA · Traditional | 07/11/2025SE |
| K251578 | Beautifil IIEBF · Traditional | 05/27/2025SE |
| K233161 | BeautiLink SAEMA · Traditional | 09/28/2023SE |
| K222253 | GlasIonomer FX ULTRAEMA · Traditional | 09/22/2022SE |
| K213965 | BeautiBond XtremeKLE · Traditional | 03/18/2022SE |
| K212939 | Vintage Prime PressEIH · Traditional | 03/18/2022SE |
| K200470 | Shofu Block HC HardEBF · Traditional | 02/05/2021SE |
| K191794 | Vintage Art UniversalEIH · Traditional | 10/03/2019SE |
Questions and answers
When was Shofu Resin Glaze cleared by the FDA?
Shofu Resin Glaze (K163568) received a 510(k) decision of Substantially Equivalent on August 16, 2017, 240 days after the submission was received.
What is the product code of K163568?
The FDA product code is EBD – Coating, Filling Material, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3310.