Conversil FL and Conversil P
FDA 510(k) K913583 · Wilde-USA, Inc.
510(k) numberK913583
Submission
- Device name
- Conversil FL and Conversil P
- Applicant
- Wilde-USA, Inc.
Chicago, IL, US - Received
- August 12, 1991
- Decision date
- November 13, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| 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 |
More from Hdi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K913582 | Compatit RELM · Traditional | 06/24/1993SE |
| K915653 | KeramailEIH · Traditional | 04/08/1993SE |
| K913581 | Wilde Adhesive Bonding SystemKLE · Traditional | 02/26/1993SE |
| K923472 | CompacolorEBF · Traditional | 10/13/1992SE |
| K920649 | CompasepFMC · Traditional | 07/23/1992SE |
| K915250 | Wil-Pds & Wil-Pdi Casting AlloysEJH · Traditional | 04/21/1992SE |
| K913089 | Wilde Light Curing Composite Restorative ResinsEBF · Traditional | 04/21/1992SE |
| K912990 | ConverbaseEBI · Traditional | 03/25/1992SE |
| K920557 | Wil-O-Dont Orthodontic Material/Wil-O-LuxEBI · Traditional | 03/20/1992SE |
| K915654 | Keralloy-D CapsEJJ · Traditional | 03/02/1992SE |
Questions and answers
When was Conversil FL and Conversil P cleared by the FDA?
Conversil FL and Conversil P (K913583) received a 510(k) decision of Substantially Equivalent on November 13, 1991, 93 days after the submission was received.
What is the product code of K913583?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.