Flash Ar; Flash Ar Quick
FDA 510(k) K133436 · 3M Deutschland GmbH
510(k) numberK133436
Submission
- Device name
- Flash Ar; Flash Ar Quick
- Applicant
- 3M Deutschland GmbH
Seefeld, DE - Received
- November 8, 2013
- Decision date
- March 7, 2014
- 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 |
|---|---|---|
| K220257 | PermadyneELW · Traditional | 02/01/2022SE |
| K192992 | Suglue 3EMA · Traditional | 11/05/2019SE |
| K192961 | ADH19KLE · Traditional | 10/31/2019SE |
| K173318 | Rapid HB, Rapid LB, Rapid MBELW · Traditional | 10/31/2017SE |
| K161922 | XP202EIH · Traditional | 09/01/2016SE |
| K153174 | Ketac Universal AplicapEMA · Traditional | 04/13/2016SE |
| K151748 | Clean & MorePIP · Traditional | 03/11/2016SE |
| K151144 | SuPro 100EBG · Traditional | 09/14/2015SE |
| K140684 | Clinpro Prophy PowderPIP · Traditional | 10/24/2014SE |
| K131404 | Flash Ar Penta / Flash Ar Penta QuickELW · Traditional | 05/30/2013SE |
Questions and answers
When was Flash Ar; Flash Ar Quick cleared by the FDA?
Flash Ar; Flash Ar Quick (K133436) received a 510(k) decision of Substantially Equivalent on March 7, 2014, 119 days after the submission was received.
What is the product code of K133436?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.