Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive
FDA 510(k) K960547 · Espe GmbH & Co. Kg.
510(k) numberK960547
Submission
- Device name
- Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive
- Applicant
- Espe GmbH & Co. Kg.
Seefeld, DE - Received
- February 8, 1996
- Decision date
- March 15, 1996
- 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 |
|---|---|---|
| K974231 | Position Penta, Position Penta QuickELW · Traditional | 01/29/1998SE |
| K973513 | Sinfony Dentin, Opaque-Dentin, Enamel, Enamel Modifier, Transparent Opal,Sinfony Magic…EBF · Traditional | 12/22/1997SE |
| K973262 | Ketac-Fil Aplicap PlusEMA · Traditional | 11/17/1997SE |
| K972892 | Cavit-LcEBF · Traditional | 10/02/1997SE |
| K963735 | Cojet SystemEBF · Traditional | 11/27/1996SE |
| K963737 | Hycem AplicapEMA · Traditional | 11/15/1996SE |
| K962428 | Ebs (Espe Bonding System)KLE · Traditional | 09/12/1996SE |
| K962442 | Hytac Aplitip/Hytac OsbEBF · Traditional | 09/11/1996SE |
| K962440 | Pertac Ii/Pertac II AplitipEBF · Traditional | 09/11/1996SE |
| K960954 | Ketac-Molar AplicapEMA · Traditional | 05/16/1996SE |
Questions and answers
When was Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive cleared by the FDA?
Dimension Penta/Dimension Garant L/Polyvinyl Siloxane Adhesive (K960547) received a 510(k) decision of Substantially Equivalent on March 15, 1996, 36 days after the submission was received.
What is the product code of K960547?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.