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FDA 510(k)

EVOLUX CAD/CAM PMMA BLOCKS

K-Number: K182065 · 2018-12-13

ApplicantBlue Dent Dental
Decision Date2018-12-13
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EVOLUX CAD/CAM PMMA BLOCKS is the device name listed in this FDA 510(k) record. The listed applicant is Blue Dent Dental. It received FDA 510(k) clearance on 2018-12-13 under 510(k) number K182065. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVOLUX CAD/CAM PMMA BLOCKS?

EVOLUX CAD/CAM PMMA BLOCKS is a medical device that received FDA 510(k) clearance on 2018-12-13. The listed applicant is Blue Dent Dental. The 510(k) number is K182065.

When did EVOLUX CAD/CAM PMMA BLOCKS receive FDA 510(k) clearance?

EVOLUX CAD/CAM PMMA BLOCKS received FDA 510(k) clearance on 2018-12-13, under 510(k) number K182065.

Who is the listed applicant for EVOLUX CAD/CAM PMMA BLOCKS?

The FDA 510(k) record lists Blue Dent Dental as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVOLUX CAD/CAM PMMA BLOCKS?

The FDA product code for EVOLUX CAD/CAM PMMA BLOCKS is EBG.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07632443PMCF Study on The Performance and Safety of ON DENT® PMMA Discs/Blocks and Resin Products for Temporary RestorationsRECRUITINGNCT07633574Additive vs Subtractive Manufacturing for Endocrown Fabrication: A 24-Month RCTNOT_YET_RECRUITING

Related Devices (Code: EBG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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