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FDA 510(k)

SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow

K-Number: K221255 · 2022-08-31

ApplicantKerr Corporation
Decision Date2022-08-31
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow is a medical device manufactured by Kerr Corporation. It received FDA 510(k) clearance on 2022-08-31 under approval number K221255. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow?

SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow is a medical device that received FDA 510(k) clearance on 2022-08-31. It is manufactured by Kerr Corporation. The 510(k) number is K221255.

When was SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow approved by the FDA?

SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow received FDA 510(k) clearance on 2022-08-31, under approval number K221255.

What company makes SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow?

SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow is manufactured by Kerr Corporation.

What is the FDA product code for SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow?

The FDA product code for SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow is EBF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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