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FDA 510(k)

CERANA

K-Number: K992161 · 1999-09-22

ApplicantNordiska Dental AB
Decision Date1999-09-22
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERANA is the device name listed in this FDA 510(k) record. The listed applicant is Nordiska Dental AB. It received FDA 510(k) clearance on 1999-09-22 under 510(k) number K992161. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERANA?

CERANA is a medical device that received FDA 510(k) clearance on 1999-09-22. The listed applicant is Nordiska Dental AB. The 510(k) number is K992161.

When did CERANA receive FDA 510(k) clearance?

CERANA received FDA 510(k) clearance on 1999-09-22, under 510(k) number K992161.

Who is the listed applicant for CERANA?

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

What is the FDA product code for CERANA?

The FDA product code for CERANA is EIH.

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 Nordiska Dental AB 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.

K002811ANA 70 NON GAMMA 2 DISPERSED PHASE DENTAL ALLOYK002810ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOYK002808ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER DENTAL ALLOY

Related Devices (Code: EIH)

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.

K262074Any-ZircosMediclus Co., Ltd.K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba DandyK260918Zolid LunarisAmann Girrbach AGK260859Rosetta SM, Rosetta SPHass Corp.

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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