FDA.reportPublic FDA data

510(k) K221851

Device
Lumina-PTFE Titanium
Applicant
Criteria Industria E Comercio DE Produtos Medicinais
510(k) number
K221851
Product code
NPK
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-08
Date received
2022-06-27
Regulation
872.3930
Classification name
Barrier, Synthetic, Intraoral
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Andre Hamar Braga
Address
E Odontologicos Ltda Alameda Sinlioku Tanaka, 170, Galpao 44- Parque Technologico Sao Carlos BR 13.565-261 13.565-261

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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