Plastalgin and Plastalgin Ortho
FDA 510(k) K032708 · Septodont
510(k) numberK032708
Submission
- Device name
- Plastalgin and Plastalgin Ortho
- Applicant
- Septodont
Washington, DC, US - Received
- September 2, 2003
- Decision date
- November 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
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| 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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| 510(k) | Device | Decision |
|---|---|---|
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2gKIF · Traditional | 09/16/2021SE |
| K211799 | Biodentine XP 500, Biodentine XP 200KIF · Traditional | 08/10/2021SE |
| K172839 | EndosolvKIF · Traditional | 02/13/2018SE |
| K140132 | BiodentineKIF · Traditional | 06/27/2014SE |
| K093711 | RacegelMVL · Traditional | 02/17/2010SE |
| K092251 | BiodentineKIF · Traditional | 10/30/2009SE |
| K063634 | RTR SyringeLYC · Abbreviated | 05/11/2007SE |
| K051010 | Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special | 05/02/2005SE |
| K780003 | Endosolv EKJJ · Traditional | 01/20/1978SE |
| K771114 | NeutrocimEMA · Traditional | 01/04/1978SE |
Questions and answers
When was Plastalgin and Plastalgin Ortho cleared by the FDA?
Plastalgin and Plastalgin Ortho (K032708) received a 510(k) decision of Substantially Equivalent on November 20, 2003, 79 days after the submission was received.
What is the product code of K032708?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.