Dentca Denture Base II
FDA 510(k) K162044 · Dentca, Inc.
510(k) numberK162044
Submission
- Device name
- Dentca Denture Base II
- Applicant
- Dentca, Inc.
Torrance, CA, US - Received
- July 25, 2016
- Decision date
- March 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Guangzhou Heygears IMC., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261474 | DENTCA Tru FlexibleEBI · Traditional | 07/01/2026SE |
| K220042 | Dentca Base Premium, Dentca Base Hi-ImpactEBI · Traditional | 11/17/2022SE |
| K192806 | DENTCA Crown and BridgeEBG · Traditional | 02/05/2020SE |
| K172398 | DENTCA DENTURE TeethPZY · Traditional | 11/22/2017SE |
| K143033 | Dentca Denture BaseEBI · Traditional | 07/21/2015SE |
Questions and answers
When was Dentca Denture Base II cleared by the FDA?
Dentca Denture Base II (K162044) received a 510(k) decision of Substantially Equivalent on March 3, 2017, 221 days after the submission was received.
What is the product code of K162044?
The FDA product code is EBI – Resin, Denture, Relining, Repairing, Rebasing, a Class II (moderate risk) device regulated under 21 CFR 872.3760.