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FDA 510(k)

UltraThineer Zirconia Slurry (5Y-B)

K-Number: K240419 · 2024-04-12

ApplicantBoston Micro Fabrication
Decision Date2024-04-12
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

UltraThineer Zirconia Slurry (5Y-B) is a medical device manufactured by Boston Micro Fabrication. It received FDA 510(k) clearance on 2024-04-12 under approval number K240419. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UltraThineer Zirconia Slurry (5Y-B)?

UltraThineer Zirconia Slurry (5Y-B) is a medical device that received FDA 510(k) clearance on 2024-04-12. It is manufactured by Boston Micro Fabrication. The 510(k) number is K240419.

When was UltraThineer Zirconia Slurry (5Y-B) approved by the FDA?

UltraThineer Zirconia Slurry (5Y-B) received FDA 510(k) clearance on 2024-04-12, under approval number K240419.

What company makes UltraThineer Zirconia Slurry (5Y-B)?

UltraThineer Zirconia Slurry (5Y-B) is manufactured by Boston Micro Fabrication.

What is the FDA product code for UltraThineer Zirconia Slurry (5Y-B)?

The FDA product code for UltraThineer Zirconia Slurry (5Y-B) is EIH.

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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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