CediTEC
FDA 510(k) K220743 · Voco GmbH
510(k) numberK220743
Submission
- Device name
- CediTEC
- Applicant
- Voco GmbH
Cuxhaven, DE - Received
- March 14, 2022
- Decision date
- July 5, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| K262300 | Denture Base Resin V2EBI · Abbreviated | Formlabs Ohio, Inc. | 07/08/2026SE |
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| 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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| K231817 | AlignerFlow LCDYH · Traditional | 12/01/2023SE |
| K231591 | V-Print c&b tempPOW · Traditional | 07/31/2023SE |
| K230877 | Admira Fusion 5EBF · Traditional | 07/13/2023SE |
| K220236 | V-Print dentbaseEBI · Traditional | 09/21/2022SE |
| K220640 | Bifix Hybrid Abutment CementEMA · Traditional | 08/23/2022SE |
Questions and answers
When was CediTEC cleared by the FDA?
CediTEC (K220743) received a 510(k) decision of Substantially Equivalent on July 5, 2022, 113 days after the submission was received.
What is the product code of K220743?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.