K-number	K251148
Device name	JDEvolution Plus L and JDEvolution Plus LE
Applicant	Jdentalcare Srl
Product code	DZE
Device class	Class II
Decision date	Sep 25, 2025
Decision	Substantially Equivalent
Regulation	872.3640

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The JDEvolution Plus L and JDEvolution Plus LE are endosseous dental implants intended for use in dental implant surgery. These Class II devices are designed to be surgically placed into the jawbone to support dental prosthetics.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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JDEvolution Plus L and JDEvolution Plus LE

Everything you need for a 510(k) submission. Nothing you don't.