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FDA 510(k)

CERA E DENTAL ALLOY

K-Number: K980661 · 1998-05-01

ApplicantEuropean Dental Imports, Inc.
Decision Date1998-05-01
Product CodeEJS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERA E DENTAL ALLOY is the device name listed in this FDA 510(k) record. The listed applicant is European Dental Imports, Inc.. It received FDA 510(k) clearance on 1998-05-01 under 510(k) number K980661. The device is classified under product code EJS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERA E DENTAL ALLOY?

CERA E DENTAL ALLOY is a medical device that received FDA 510(k) clearance on 1998-05-01. The listed applicant is European Dental Imports, Inc.. The 510(k) number is K980661.

When did CERA E DENTAL ALLOY receive FDA 510(k) clearance?

CERA E DENTAL ALLOY received FDA 510(k) clearance on 1998-05-01, under 510(k) number K980661.

Who is the listed applicant for CERA E DENTAL ALLOY?

The FDA 510(k) record lists European Dental Imports, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CERA E DENTAL ALLOY?

The FDA product code for CERA E DENTAL ALLOY is EJS.

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 European Dental Imports, Inc. 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.

K982129ANTAGON PORCELAINK981001ORION VESTA DENTAL ALLOYK981002ORION WX DENTAL ALLOYK981000CARRARA PORCELAIN AND CARRARA VINCENT PORCELAINK980660BIOGOLD PLUS DENTAL ALLOYK980597CARRARA PDF, CARRARA H, CARRARA R

View all 7 devices →

Related Devices (Code: EJS)

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.

K041433BRIGHT GOLD XHIvoclar Vivadent, Inc.K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KGK022252STERNGOLD 1, MODEL 1127781SterngoldK022469ECO E4Wieland Dental + Technik GmbH & Co. KGK021367STERNGOLD 66, MODEL #1180230SterngoldK020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG

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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