Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light
FDA 510(k) K113279 · Kettenbach GmbH & Co. KG
510(k) numberK113279
Submission
- Device name
- Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light
- Applicant
- Kettenbach GmbH & Co. KG
Eschenburg, DE - Received
- November 7, 2011
- Decision date
- November 14, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K262243 | Profisil FreeLBH · Traditional | 09/03/2026SE |
| K250267 | Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062)…EBF · Traditional | 03/14/2025SE |
| 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 |
| K092867 | Identium Heavy, Medium, Medium Soft, LightELW · Traditional | 10/01/2009SE |
| K083701 | Panasil Initial Contact and Panasil TrayELW · Special | 01/09/2009SE |
Questions and answers
When was Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light cleared by the FDA?
Identium Heavy, Identium Medium, Identium Scan Heavy, Identium Scan Medium, Identium Scan Light (K113279) received a 510(k) decision of Substantially Equivalent on November 14, 2011, 7 days after the submission was received.
What is the product code of K113279?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.