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FDA 510(k)

PERTAC UNIVERSAL BOND

K-Number: K904289 · 1990-11-01

ApplicantEspe GmbH (Us)
Decision Date1990-11-01
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PERTAC UNIVERSAL BOND 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 1990-11-01 under 510(k) number K904289. 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 PERTAC UNIVERSAL BOND?

PERTAC UNIVERSAL BOND is a medical device that received FDA 510(k) clearance on 1990-11-01. The listed applicant is Espe GmbH (Us). The 510(k) number is K904289.

When did PERTAC UNIVERSAL BOND receive FDA 510(k) clearance?

PERTAC UNIVERSAL BOND received FDA 510(k) clearance on 1990-11-01, under 510(k) number K904289.

Who is the listed applicant for PERTAC UNIVERSAL BOND?

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 PERTAC UNIVERSAL BOND?

The FDA product code for PERTAC UNIVERSAL BOND 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.

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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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