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FDA 510(k)

DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR

K-Number: K152215 · 2016-01-19

ApplicantDentalplus GmbH
Decision Date2016-01-19
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR is the device name listed in this FDA 510(k) record. The listed applicant is Dentalplus GmbH. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K152215. 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 DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR?

DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Dentalplus GmbH. The 510(k) number is K152215.

When did DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR receive FDA 510(k) clearance?

DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR received FDA 510(k) clearance on 2016-01-19, under 510(k) number K152215.

Who is the listed applicant for DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR?

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

What is the FDA product code for DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR?

The FDA product code for DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR is EBG.

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

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

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