Rainbow 360
FDA 510(k) K222830 · Kerr Corporation
510(k) numberK222830
Submission
- Device name
- Rainbow 360
- Applicant
- Kerr Corporation
Pomona, CA, US - Received
- September 19, 2022
- Decision date
- January 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Rizhao Huge Biomaterials Company, Ltd.
| 510(k) | Device | Decision |
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| K252890 | ZenSeal ProKIF · Traditional | 01/07/2026SE |
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| K182162 | OptiBond eXTRa UniversalKLE · Traditional | 11/07/2018SE |
| 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 |
| K162257 | P1145 Dental RestorativeEBF · Traditional | 11/07/2016SE |
Questions and answers
When was Rainbow 360 cleared by the FDA?
Rainbow 360 (K222830) received a 510(k) decision of Substantially Equivalent on January 12, 2023, 115 days after the submission was received.
What is the product code of K222830?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.