Lexatite Quick Acrylic
FDA 510(k) K033432 · Imtec Corp.
510(k) numberK033432
Submission
- Device name
- Lexatite Quick Acrylic
- Applicant
- Imtec Corp.
Ardmore, OK, US - Received
- October 28, 2003
- Decision date
- January 15, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K081653 | Mdi Mii One-Piece Implant, 2.9MMDZE · Traditional | 09/19/2008SE |
| K081347 | Iluma VisionLLZ · Traditional | 05/28/2008SE |
| K072660 | Endure Implant, Model 5108, 5111, 5113, 5114DZE · Traditional | 12/12/2007SE |
| K053046 | Iluma Orthocat/DentalcatJAK · Abbreviated | 11/08/2005SE |
| K043226 | Endure Implant, Models 3508, 4308, 3520, 4320DZE · Traditional | 01/13/2005SE |
| K042289 | Mdi OrthoDZE · Traditional | 09/15/2004SE |
| K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models Ob-Xx, Sh-Xx, MOB-22, Msh-XxDZE · Traditional | 08/12/2003SE |
| K030243 | Endure Implant, Model 3508,3511,3514,4308,4311,4314DZE · Traditional | 04/23/2003SE |
| K024044 | Saber Tech Implants SystemDZE · Traditional | 02/21/2003SE |
| K023067 | Imtec Sendax Mdi ORTHO6 and ORTHO8DZE · Traditional | 12/03/2002SE |
Questions and answers
When was Lexatite Quick Acrylic cleared by the FDA?
Lexatite Quick Acrylic (K033432) received a 510(k) decision of Substantially Equivalent on January 15, 2004, 79 days after the submission was received.
What is the product code of K033432?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.