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FDA 510(k)

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST

K-Number: K250969 · 2025-06-27

ApplicantDent4you AG
Decision Date2025-06-27
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is a medical device manufactured by Dent4you AG. It received FDA 510(k) clearance on 2025-06-27 under approval number K250969. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is a medical device that received FDA 510(k) clearance on 2025-06-27. It is manufactured by Dent4you AG. The 510(k) number is K250969.

When was JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST approved by the FDA?

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST received FDA 510(k) clearance on 2025-06-27, under approval number K250969.

What company makes JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is manufactured by Dent4you AG.

What is the FDA product code for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST?

The FDA product code for JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST is ELW.

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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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