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FDA 510(k)

NIMETIC BONDING MATERIAL

K-Number: K771326 · 1977-08-02

ApplicantEspe GmbH (Us)
Decision Date1977-08-02
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NIMETIC BONDING MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Espe GmbH (Us). It received FDA 510(k) clearance on 1977-08-02 under 510(k) number K771326. 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 NIMETIC BONDING MATERIAL?

NIMETIC BONDING MATERIAL is a medical device that received FDA 510(k) clearance on 1977-08-02. The listed applicant is Espe GmbH (Us). The 510(k) number is K771326.

When did NIMETIC BONDING MATERIAL receive FDA 510(k) clearance?

NIMETIC BONDING MATERIAL received FDA 510(k) clearance on 1977-08-02, under 510(k) number K771326.

Who is the listed applicant for NIMETIC BONDING MATERIAL?

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

What is the FDA product code for NIMETIC BONDING MATERIAL?

The FDA product code for NIMETIC BONDING MATERIAL is KLE.

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Other records listing Espe GmbH (Us) 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.

K925027PHOTAC-FIL APLICAPK913966SONO(R) -CEMK915005PHOTAC-BOND APLICAP, MODIFICATIONK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEM

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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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