dima Print Teeth & Temp
FDA 510(k) K233868 · Kulzer, LLC
510(k) numberK233868
Submission
- Device name
- dima Print Teeth & Temp
- Applicant
- Kulzer, LLC
South Bend, IN, US - Received
- December 6, 2023
- Decision date
- May 23, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261261 | Dura-ArchEBG · Traditional | Hangzhou SHINING3D Dental Technology Co., Ltd. | 04/17/2026SE |
| K253380 | FLNT Base and FLNT TempEBG · Traditional | Liaoning Upcera Co., Ltd. | 03/02/2026SE |
| K251271 | TempFIT Temporary Crown and Bridge ResinEBG · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 06/23/2025SE |
| K243370 | DentaTOOTHEBG · Traditional | Asiga Pty, Ltd. | 05/05/2025SE |
| K243621 | Evoblock, PerléonEBG · Traditional | Evoden Indústria Comércio Importação E Exportação | 04/22/2025SE |
| K243951 | TEMP MASTER, PMMA-based dental resinEBG · Traditional | Taiwan Dental Materials Co., Ltd. | 02/21/2025SE |
| K242559 | Digital TempEBG · Traditional | Sprintray, Inc. | 11/26/2024SE |
| K231859 | PrimmaArtEBG · Traditional | Dentscare Ltda | 11/26/2024SE |
| K240538 | Premium Teeth ResinEBG · Traditional | Formlabs Ohio, Inc. | 07/19/2024SE |
| K241226 | Fixtemp® C&B 4:1EBG · Special | Dreve Denatmid GmbH | 05/31/2024SE |
More from Dreve Denatmid GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow OneEBF · Traditional | 03/11/2026SE |
| K254063 | iCEM Universal PlusEMA · Abbreviated | 12/19/2025SE |
| K243910 | RetraxilMVL · Traditional | 09/24/2025SE |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite…EBF · Traditional | 09/17/2024SE |
| K230644 | Signum opaque FEBF · Traditional | 09/07/2023SE |
| K220605 | Venus Bulk Flow ONEEBF · Special | 04/21/2022SE |
| K905058 | Palavit LEBH · Traditional | 06/06/1991SE |
| K904928 | Palavit GLCEGD · Traditional | 06/06/1991SE |
| K910263 | CharismaEBF · Traditional | 06/03/1991SE |
| K910719 | Silicoater MDEMA · Traditional | 04/29/1991SE |
Questions and answers
When was dima Print Teeth & Temp cleared by the FDA?
dima Print Teeth & Temp (K233868) received a 510(k) decision of Substantially Equivalent on May 23, 2024, 169 days after the submission was received.
What is the product code of K233868?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.