FotoDent denture
FDA 510(k) K200580 · Dreve Dentamid GmbH
510(k) numberK200580
Submission
- Device name
- FotoDent denture
- Applicant
- Dreve Dentamid GmbH
Unna, DE - Received
- March 5, 2020
- Decision date
- November 19, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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| K261802 | Glidewell Denture Base ResinEBI · Traditional | Prismatik Dentalcraft, Inc. | 08/27/2026SE |
| K261626 | UltraPrint Flexible Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 08/13/2026SE |
| K262681 | NanoCeram ResinEBI · Traditional | 3BFAB Teknoloji A.S. | 07/31/2026SE |
| K262300 | Denture Base Resin V2EBI · Abbreviated | Formlabs Ohio, Inc. | 07/08/2026SE |
| K261474 | DENTCA Tru FlexibleEBI · Traditional | Dentca, Inc. | 07/01/2026SE |
| K260569 | DB 4000 High Impact Denture BaseEBI · Abbreviated | Carbon, Inc. | 06/02/2026SE |
| K260376 | Denture BaseEBI · Traditional | Shandong Huge Dental Material Corporation | 05/06/2026SE |
| K253365 | LuxCreo Flexible Partial Denture ResinEBI · Traditional | LuxCreo, Inc. | 11/25/2025SE |
| K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard…EBI · Traditional | Graphy, Inc. | 11/21/2025SE |
| K253324 | UltraPrint-Dental Denture UVEBI · Traditional | Guangzhou Heygears IMC., Inc. | 11/20/2025SE |
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| 510(k) | Device | Decision |
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| K250739 | Primeprint Direct AlignerNXC · Traditional | 11/07/2025SE |
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| K162408 | Nano Varnish, Plaquit, Lightpaint on SurfaceEBD · Traditional | 04/05/2018SE |
| K171729 | Fixtemp C&BEBG · Traditional | 12/13/2017SE |
Questions and answers
When was FotoDent denture cleared by the FDA?
FotoDent denture (K200580) received a 510(k) decision of Substantially Equivalent on November 19, 2020, 259 days after the submission was received.
What is the product code of K200580?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.