K-number	K243621
Device name	Evoblock, Perléon
Applicant	Evoden Indústria Comércio Importação E Exportação
Product code	EBG
Device class	Class II
Decision date	Apr 22, 2025
Decision	Substantially Equivalent
Regulation	872.3770

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Evoblock/Perléon is a temporary crown and bridge resin used in dentistry for creating temporary anterior and posterior crowns, implant and abutment-supported prosthetics, and partial, complete, and hybrid denture prosthetics (base and teeth). It is prescribed for use by dental professionals.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

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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Evoblock, Perléon

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