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FDA 510(k)

EBS (ESPE BONDING SYSTEM)

K-Number: K962428 · 1996-09-12

ApplicantEspe GmbH & Co. Kg.
Decision Date1996-09-12
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EBS (ESPE BONDING SYSTEM) 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 1996-09-12 under 510(k) number K962428. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EBS (ESPE BONDING SYSTEM)?

EBS (ESPE BONDING SYSTEM) is a medical device that received FDA 510(k) clearance on 1996-09-12. The listed applicant is Espe GmbH & Co. Kg.. The 510(k) number is K962428.

When did EBS (ESPE BONDING SYSTEM) receive FDA 510(k) clearance?

EBS (ESPE BONDING SYSTEM) received FDA 510(k) clearance on 1996-09-12, under 510(k) number K962428.

Who is the listed applicant for EBS (ESPE BONDING SYSTEM)?

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 EBS (ESPE BONDING SYSTEM)?

The FDA product code for EBS (ESPE BONDING SYSTEM) is KLE.

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 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 OPAQUERK973262KETAC-FIL APLICAP PLUSK972892CAVIT-LCK963735COJET SYSTEMK963737HYCEM APLICAP

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Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter 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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