S & C Vinyl Polysiloxane Impression Material
FDA 510(k) K951075 · S & C Polymer GmbH
510(k) numberK951075
Submission
- Device name
- S & C Vinyl Polysiloxane Impression Material
- Applicant
- S & C Polymer GmbH
Elmshorn, DE - Received
- March 9, 1995
- Decision date
- March 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code ELW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated | Dent4you AG | 06/27/2025SE |
| 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 |
More from Hdi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K091735 | DC Provi Cem Esthetic, Esthetic Multi F, ImplantEMA · Traditional | 09/25/2009SE |
| K083062 | Root Canal XRKIF · Traditional | 03/12/2009SE |
| K083766 | Phoglass CemEMA · Traditional | 03/02/2009SE |
| K082115 | Phoglass Fill, Core, Cem, Seal, Prime and Phoglass ProtectEMA · Traditional | 01/15/2009SE |
| K081702 | Carboxylate Cem, Phosphate CemEMA · Traditional | 09/05/2008SE |
| K042614 | S&C-Self Etch Pr-BondKLE · Traditional | 11/22/2004SE |
| K031420 | S & C -Bracket AdhesivesDYH · Traditional | 08/20/2003SE |
| K012767 | S & C Hydro Vinyl Polysiloxane Impression MaterialELW · Traditional | 11/01/2001SE |
| K011277 | Hard RelinerEBI · Traditional | 06/26/2001SE |
| K011431 | Resin CemEMA · Traditional | 06/11/2001SE |
Questions and answers
When was S & C Vinyl Polysiloxane Impression Material cleared by the FDA?
S & C Vinyl Polysiloxane Impression Material (K951075) received a 510(k) decision of Substantially Equivalent on March 31, 1995, 22 days after the submission was received.
What is the product code of K951075?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.