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FDA 510(k)

ESPE(R) -SIL

K-Number: K913965 · 1991-12-04

ApplicantEspe GmbH (Us)
Decision Date1991-12-04
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ESPE(R) -SIL 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 1991-12-04 under 510(k) number K913965. 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 ESPE(R) -SIL?

ESPE(R) -SIL is a medical device that received FDA 510(k) clearance on 1991-12-04. The listed applicant is Espe GmbH (Us). The 510(k) number is K913965.

When did ESPE(R) -SIL receive FDA 510(k) clearance?

ESPE(R) -SIL received FDA 510(k) clearance on 1991-12-04, under 510(k) number K913965.

Who is the listed applicant for ESPE(R) -SIL?

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 ESPE(R) -SIL?

The FDA product code for ESPE(R) -SIL is KLE.

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 APLICAPK915005PHOTAC-BOND APLICAP, MODIFICATIONK913966SONO(R) -CEMK913857ROCATEC(R) -PLUSK905604VISIO-GEM ART-SYSTEMK904096PHOTAC-BOND

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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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