Infinity / Infinity Cross Flex Dental Systems

Unit, Operative Dental

Olsen Insdustria De Equipamentos Odontomedicos

The following data is part of a premarket notification filed by Olsen Insdustria De Equipamentos Odontomedicos with the FDA for Infinity / Infinity Cross Flex Dental Systems.

Pre-market Notification Details

Device IDK180935
510k NumberK180935
Device Name:Infinity / Infinity Cross Flex Dental Systems
ClassificationUnit, Operative Dental
Applicant Olsen Insdustria De Equipamentos Odontomedicos Av. Ivo Luchi, 68 - Jardim Eldorado Palhoça -,  BR 88133-510
ContactAna Claudia Espindola
CorrespondentLilian Llull
TechLink International 16445 Collins Ave # 522 Sunny Isles,  FL  33160
Product CodeEIA  
CFR Regulation Number872.6640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
510k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-10
Decision Date2020-02-05

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