Prelude (Temporary Crown and Bridge Cement)
FDA 510(k) K901077 · Scientific Pharmaceuticals, Inc.
510(k) numberK901077
Submission
- Device name
- Prelude (Temporary Crown and Bridge Cement)
- Applicant
- Scientific Pharmaceuticals, Inc.
Duarte, CA, US - Received
- March 7, 1990
- Decision date
- May 29, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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|---|---|---|---|
| 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 |
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| 510(k) | Device | Decision |
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| K051952 | EugenoneEMA · Traditional | 09/07/2005SE |
| K041886 | ProvisoEBG · Traditional | 08/04/2004SE |
| K013555 | Sci-Pharm Post SecureEMA · Traditional | 01/23/2002SE |
| K001446 | Light-Cured Orthodontic Band CementDYH · Traditional | 07/21/2000SE |
| K993324 | Carbocem Zinc Polycarboxylate CementEMA · Traditional | 11/09/1999SE |
| K982915 | Sci-Pharm DFV VarnishLBH · Traditional | 02/12/1999SE |
| K983305 | Sci-Pharm Desensitizing VarnishLBH · Traditional | 12/17/1998SE |
| K982913 | Zinfos Zinc Phosphate CementEMA · Traditional | 10/19/1998SE |
| K944466 | SealdentEBI · Traditional | 03/02/1995SE |
Questions and answers
When was Prelude (Temporary Crown and Bridge Cement) cleared by the FDA?
Prelude (Temporary Crown and Bridge Cement) (K901077) received a 510(k) decision of Substantially Equivalent on May 29, 1990, 83 days after the submission was received.
What is the product code of K901077?
The FDA product code is EBG – Crown And Bridge, Temporary, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3770.