SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
FDA 510(k) K221255 · Kerr Corporation
510(k) numberK221255
Submission
- Device name
- SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow
- Applicant
- Kerr Corporation
Pomona, CA, US - Received
- May 2, 2022
- Decision date
- August 31, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K162436 | EndoVac PureNYL · Traditional | 12/21/2016SE |
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Questions and answers
When was SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow cleared by the FDA?
SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow (K221255) received a 510(k) decision of Substantially Equivalent on August 31, 2022, 121 days after the submission was received.
What is the product code of K221255?
The FDA product code is EBF – Material, Tooth Shade, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3690.