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FDA 510(k)

COPRA TEMP PMMA-DISK

K-Number: K131664 · 2013-12-18

ApplicantWhite Peaks Dental Systems GmbH & Co. KG
Decision Date2013-12-18
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COPRA TEMP PMMA-DISK is the device name listed in this FDA 510(k) record. The listed applicant is White Peaks Dental Systems GmbH & Co. KG. It received FDA 510(k) clearance on 2013-12-18 under 510(k) number K131664. 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 COPRA TEMP PMMA-DISK?

COPRA TEMP PMMA-DISK is a medical device that received FDA 510(k) clearance on 2013-12-18. The listed applicant is White Peaks Dental Systems GmbH & Co. KG. The 510(k) number is K131664.

When did COPRA TEMP PMMA-DISK receive FDA 510(k) clearance?

COPRA TEMP PMMA-DISK received FDA 510(k) clearance on 2013-12-18, under 510(k) number K131664.

Who is the listed applicant for COPRA TEMP PMMA-DISK?

The FDA 510(k) record lists White Peaks Dental Systems GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COPRA TEMP PMMA-DISK?

The FDA product code for COPRA TEMP PMMA-DISK 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing White Peaks Dental Systems GmbH & Co. KG as applicant

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.

K123680COPRANCOLORK092496COPRAN ZR/ORIGIN YZ

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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