Flash (Different Materials)
FDA 510(k) K120438 · 3M Deutschland GmbH
510(k) numberK120438
Submission
- Device name
- Flash (Different Materials)
- Applicant
- 3M Deutschland GmbH
Bavaria D-82228 Seefeld, DE - Received
- February 13, 2012
- Decision date
- May 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| 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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| 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 |
| K133436 | Flash Ar; Flash Ar QuickELW · Traditional | 03/07/2014SE |
Questions and answers
When was Flash (Different Materials) cleared by the FDA?
Flash (Different Materials) (K120438) received a 510(k) decision of Substantially Equivalent on May 2, 2012, 79 days after the submission was received.
What is the product code of K120438?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.