Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast

FDA 510(k) K250969 · Dent4you AG

Substantially Equivalent

510(k) numberK250969

Submission

Device name
Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast
Applicant
Dent4you AG
Heerbrugg, CH
Received
March 31, 2025
Decision date
June 27, 2025
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ELW – Material, Impression
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3660
Specialty
Dental

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More from Prevest Denpro Limited

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Questions and answers

When was Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast cleared by the FDA?

Jet Bite; Jet Blue Bite Fast; Jet Blue Bite Superfast (K250969) received a 510(k) decision of Substantially Equivalent on June 27, 2025, 88 days after the submission was received.

What is the product code of K250969?

The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.