Standout 2
FDA 510(k) K072622 · Kerr Corp.
510(k) numberK072622
Submission
- Device name
- Standout 2
- Applicant
- Kerr Corp.
Orange, CA, US - Received
- September 17, 2007
- Decision date
- December 4, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELW
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|---|---|---|---|
| K254112 | Dia-X Sil BiteELW · Traditional | DiaDent Group International | 03/19/2026SE |
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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 |
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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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| K162948 | Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retraction…MVL · Traditional | 08/08/2017SE |
| K163064 | Demi UltraEBZ · Special | 07/18/2017SE |
| K162536 | GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum…MVL · Traditional | 02/03/2017SE |
| K162164 | GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction CordMVL · Traditional | 01/13/2017SE |
| K162436 | EndoVac PureNYL · Traditional | 12/21/2016SE |
Questions and answers
When was Standout 2 cleared by the FDA?
Standout 2 (K072622) received a 510(k) decision of Substantially Equivalent on December 4, 2007, 78 days after the submission was received.
What is the product code of K072622?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.