Accu-Dent XD Tray, Accu-Dent XD Syringe
FDA 510(k) K143575 · Ivoclar Vivadent, Inc.
510(k) numberK143575
Submission
- Device name
- Accu-Dent XD Tray, Accu-Dent XD Syringe
- Applicant
- Ivoclar Vivadent, Inc.
Amherst, NY, US - Received
- December 17, 2014
- Decision date
- April 3, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary 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 |
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| K233995 | Ivotion Base PrintEBI · Traditional | 02/23/2024SE |
| K210804 | Adhese Universal DC, Cention PrimerKLE · Traditional | 06/07/2022SE |
| K211916 | IPS e.max OneEIH · Traditional | 08/20/2021SE |
| K193193 | Telio CAD Abutment Solutions- extra systemsNHA · Abbreviated | 11/16/2020SE |
| K191453 | Cervitec FLBH · Traditional | 02/11/2020SE |
| K191448 | Barrier SleevesPEM · Traditional | 10/08/2019SE |
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Questions and answers
When was Accu-Dent XD Tray, Accu-Dent XD Syringe cleared by the FDA?
Accu-Dent XD Tray, Accu-Dent XD Syringe (K143575) received a 510(k) decision of Substantially Equivalent on April 3, 2015, 107 days after the submission was received.
What is the product code of K143575?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.