Multiple (Addition Silicone Impression Material)
FDA 510(k) K041229 · Cosmedent, Inc.
510(k) numberK041229
Submission
- Device name
- Multiple (Addition Silicone Impression Material)
- Applicant
- Cosmedent, Inc.
Chicago, IL, US - Received
- May 10, 2004
- Decision date
- June 17, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K240714 | Insure® Universal; Insure® Universal AutomixEMA · Traditional | 07/24/2024SE |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable MicrohybridEBF · Traditional | 10/11/2022SE |
| K211259 | Renamel BulkfillEBF · Traditional | 06/24/2021SE |
| K172707 | Renamel MicrofillEBF · Traditional | 12/05/2017SE |
| K163480 | Renamel NANO +plusEBF · Traditional | 02/24/2017SE |
| K092730 | Cosmedent Brushable CompositeEBF · Traditional | 11/20/2009SE |
| K070583 | Nano CompositeEBF · Traditional | 04/16/2007SE |
| K060881 | Temporary Crown & Bridge ResinEBG · Traditional | 05/16/2006SE |
| K052263 | Multiple (Tooth Desensitizer)LBH · Traditional | 12/16/2005SE |
| K052501 | Multiple Resin Tooth Bonding AgentKLE · Traditional | 10/21/2005SE |
Questions and answers
When was Multiple (Addition Silicone Impression Material) cleared by the FDA?
Multiple (Addition Silicone Impression Material) (K041229) received a 510(k) decision of Substantially Equivalent on June 17, 2004, 38 days after the submission was received.
What is the product code of K041229?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.