Prelude
FDA 510(k) K040952 · Danville Materials, Inc.
510(k) numberK040952
Submission
- Device name
- Prelude
- Applicant
- Danville Materials, Inc.
San Ramon, CA, US - Received
- April 12, 2004
- Decision date
- June 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K260485 | Any-EtchKLE · Traditional | Mediclus Co., Ltd. | 05/14/2026SE |
| K260430 | Porcelain Etch GelKLE · Traditional | Belport Company, Inc., Gingi-Pak | 04/10/2026SE |
| K252450 | Adhese 2KLE · Traditional | Ivoclar Vivadent, Inc. | 03/05/2026SE |
| K260682 | Bond-PR Universal AdhesiveKLE · Traditional | Premier Dental Products Company | 03/03/2026SE |
| K251587 | VITA VMLC PrimerKLE · Traditional | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | 02/23/2026SE |
| K252151 | els unibondKLE · Traditional | Saremco Dental AG | 12/05/2025SE |
| K252469 | Magnabond Se; Magnabond Universal; Magnabond Universal DcaKLE · Traditional | Dmp Dental Industry S.A. | 11/06/2025SE |
| K251124 | G-Bond UniversalKLE · Traditional | GC America, Inc. | 10/02/2025SE |
| K242530 | HF-Etchant Hydrofluoric Acid Etching GelKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 12/20/2024SE |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling AgentKLE · Traditional | Rizhao Huge Biomaterials Company, Ltd. | 11/08/2024SE |
More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K152349 | Star+ VPS Scannable Impression MaterialELW · Traditional | 11/23/2015SE |
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| K151088 | DMRC Bulk FillEBF · Traditional | 08/28/2015SE |
| K142886 | DMRC Self-Cure Bracket Adhesive One Step and PrimerDYH · Traditional | 03/18/2015SE |
| K142881 | DMRC Dual Cure Orthodontic Band CementDYH · Traditional | 02/13/2015SE |
| K121880 | DMRC Nanoflow DMRC Nanocomposite Ebond Sure Etch Gel Sure Etch LiquidEBF · Traditional | 09/25/2012SE |
| K111876 | Z Bond, Prelude OneKLE · Traditional | 09/21/2011SE |
| K110642 | Siljetr SystemEBF · Traditional | 05/27/2011SE |
| K102753 | Turbo Temp 3EBG · Traditional | 02/04/2011SE |
| K092912 | Starfill 2B HV (High Viscosity) Rockcore, Model: 90838 and Starfill 2B LV (Low…EBF · Traditional | 12/16/2009SE |
Questions and answers
When was Prelude cleared by the FDA?
Prelude (K040952) received a 510(k) decision of Substantially Equivalent on June 29, 2004, 78 days after the submission was received.
What is the product code of K040952?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.