Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
FDA 510(k) K213244 · Prevest Denpro Limited
510(k) numberK213244
Submission
- Device name
- Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
- Applicant
- Prevest Denpro Limited
Bari Brahmana, IN - Received
- September 30, 2021
- Decision date
- September 9, 2022
- 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 |
|---|---|---|
| K233273 | C&B Ceramic; C&B Permanent; C&B InterimEBF · Traditional | 11/27/2024SE |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NTEBF · Traditional | 01/05/2024SE |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew UniversalKLE · Traditional | 08/11/2023SE |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…KIF · Traditional | 05/23/2022SE |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)EJK · Traditional | 05/13/2022SE |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior…EMA · Traditional | 05/13/2021SE |
Questions and answers
When was Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) cleared by the FDA?
Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) (K213244) received a 510(k) decision of Substantially Equivalent on September 9, 2022, 344 days after the submission was received.
What is the product code of K213244?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.