Future Wash/Yps
FDA 510(k) K051797 · 3M Espe AG Dental Products
510(k) numberK051797
Submission
- Device name
- Future Wash/Yps
- Applicant
- 3M Espe AG Dental Products
Bavaria D-82228 Seefeld, DE - Received
- July 5, 2005
- Decision date
- July 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K254112 | Dia-X Sil BiteELW · Traditional | DiaDent Group International | 03/19/2026SE |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional | Vigodent Indústria E Comercio Ltda | 10/31/2025SE |
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| K241924 | Elastic Impression MaterialELW · Abbreviated | Beijing Okvd Biological Technology , Ltd. | 12/27/2024SE |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…ELW · Traditional | Dent4you AG | 11/15/2024SE |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional | B&E Korea Co., Ltd. | 02/13/2024SE |
| K223892 | DentMix VPS Impression MaterialELW · Traditional | Innovative Product Brands, Inc. | 04/27/2023SE |
| K213175 | No Stress ImpressELW · Traditional | No Stress Impress, LLC | 01/19/2023SE |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
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| 510(k) | Device | Decision |
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| K100756 | MaltaEMA · Traditional | 06/02/2010SE |
| K094007 | UnicemEMA · Traditional | 04/08/2010SE |
| K093721 | COSP2MVL · Traditional | 02/19/2010SE |
| K091826 | ElegantEIH · Traditional | 09/25/2009SE |
| K090718 | Bellus Shading KitEIH · Traditional | 09/21/2009SE |
| K080514 | PECD-01 and Pecd QUICK-01ELW · Special | 03/26/2008SE |
| K072055 | Lava Frame, Lava Frame ShadeNHA · Traditional | 02/26/2008SE |
| K073296 | TEMPXN28EBG · Traditional | 01/09/2008SE |
| K071131 | UnoKLE · Traditional | 07/25/2007SE |
Questions and answers
When was Future Wash/Yps cleared by the FDA?
Future Wash/Yps (K051797) received a 510(k) decision of Substantially Equivalent on July 21, 2005, 16 days after the submission was received.
What is the product code of K051797?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.