Pro-V
FDA 510(k) K073263 · Bisco, Inc.
510(k) numberK073263
Submission
- Device name
- Pro-V
- Applicant
- Bisco, Inc.
Schaumburg, IL, US - Received
- November 20, 2007
- Decision date
- February 14, 2008
- 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 |
|---|---|---|
| K250156 | Choice 2 DCEMA · Traditional | 07/11/2025SE |
| K242816 | QuantiumEBF · Traditional | 12/17/2024SE |
| K192007 | TheraBase, TheraBase CaEMA · Traditional | 03/17/2020SE |
| K182917 | FluoroCalLBH · Traditional | 11/18/2019SE |
| K180344 | TheraCal DCEJK · Special | 04/05/2018SE |
| K171147 | REVEAL BulkEBF · Traditional | 08/04/2017SE |
| K162598 | HAPI SealEBC · Traditional | 05/23/2017SE |
| K163171 | CeraCleanPME · Traditional | 04/14/2017SE |
| K161051 | All-Bond Universal w/BAC (not finalized)KLE · Traditional | 09/09/2016SE |
| K161256 | TheraCemEMA · Traditional | 07/29/2016SE |
Questions and answers
When was Pro-V cleared by the FDA?
Pro-V (K073263) received a 510(k) decision of Substantially Equivalent on February 14, 2008, 86 days after the submission was received.
What is the product code of K073263?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.