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FDA 510(k)

KETAC-FIL APLICAP PLUS

K-Number: K973262 · 1997-11-17

ApplicantEspe GmbH & Co. Kg.
Decision Date1997-11-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KETAC-FIL APLICAP PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH & Co. Kg.. It received FDA 510(k) clearance on 1997-11-17 under 510(k) number K973262. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KETAC-FIL APLICAP PLUS?

KETAC-FIL APLICAP PLUS is a medical device that received FDA 510(k) clearance on 1997-11-17. The listed applicant is Espe GmbH & Co. Kg.. The 510(k) number is K973262.

When did KETAC-FIL APLICAP PLUS receive FDA 510(k) clearance?

KETAC-FIL APLICAP PLUS received FDA 510(k) clearance on 1997-11-17, under 510(k) number K973262.

Who is the listed applicant for KETAC-FIL APLICAP PLUS?

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

What is the FDA product code for KETAC-FIL APLICAP PLUS?

The FDA product code for KETAC-FIL APLICAP PLUS is EMA.

Related Clinical Trials

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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 Espe 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.

K974231POSITION PENTA, POSITION PENTA QUICKK973513SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUERK972892CAVIT-LCK963735COJET SYSTEMK963737HYCEM APLICAPK962428EBS (ESPE BONDING SYSTEM)

View all 17 devices →

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

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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