Identic and KromaFaze Alginate Dental Impression Materials
FDA 510(k) K160441 · Kerr Corporation
510(k) numberK160441
Submission
- Device name
- Identic and KromaFaze Alginate Dental Impression Materials
- Applicant
- Kerr Corporation
Orange, CA, US - Received
- February 17, 2016
- Decision date
- June 30, 2016
- 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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| 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 |
Questions and answers
When was Identic and KromaFaze Alginate Dental Impression Materials cleared by the FDA?
Identic and KromaFaze Alginate Dental Impression Materials (K160441) received a 510(k) decision of Substantially Equivalent on June 30, 2016, 134 days after the submission was received.
What is the product code of K160441?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.