Identium Heavy, Medium, Medium Soft, Light
FDA 510(k) K092867 · Kettenbach GmbH & Co. KG
510(k) numberK092867
Submission
- Device name
- Identium Heavy, Medium, Medium Soft, Light
- Applicant
- Kettenbach GmbH & Co. KG
Eschenburg, DE - Received
- September 18, 2009
- Decision date
- October 1, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code ELW
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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 |
| 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 |
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| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint…LBH · Traditional | 07/24/2023SE |
| K191527 | Visalys CemCore, Visalys Cem Core Try In PasteEMA · Traditional | 11/08/2019SE |
| K191523 | Visalys Restorative PrimerKLE · Traditional | 10/09/2019SE |
| K191524 | Visalys Tooth PrimerKLE · Traditional | 09/29/2019SE |
| K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-XEBF · Traditional | 03/25/2015SE |
| K122039 | Kingscross PL-C+B-10, Kingscross PL-C+B-12, Kingscross PL-C+B-08, Kingscross BEBG · Traditional | 12/27/2012SE |
| K113279 | Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium…ELW · Special | 11/14/2011SE |
| K083701 | Panasil Initial Contact and Panasil TrayELW · Special | 01/09/2009SE |
Questions and answers
When was Identium Heavy, Medium, Medium Soft, Light cleared by the FDA?
Identium Heavy, Medium, Medium Soft, Light (K092867) received a 510(k) decision of Substantially Equivalent on October 1, 2009, 13 days after the submission was received.
What is the product code of K092867?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.