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FDA 510(k)

SONO(R) -CEM

K-Number: K913966 · 1992-01-14

ApplicantEspe GmbH (Us)
Decision Date1992-01-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SONO(R) -CEM 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 1992-01-14 under 510(k) number K913966. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONO(R) -CEM?

SONO(R) -CEM is a medical device that received FDA 510(k) clearance on 1992-01-14. The listed applicant is Espe GmbH (Us). The 510(k) number is K913966.

When did SONO(R) -CEM receive FDA 510(k) clearance?

SONO(R) -CEM received FDA 510(k) clearance on 1992-01-14, under 510(k) number K913966.

Who is the listed applicant for SONO(R) -CEM?

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 SONO(R) -CEM?

The FDA product code for SONO(R) -CEM is EBF.

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, MODIFICATIONK913857ROCATEC(R) -PLUSK913965ESPE(R) -SILK905604VISIO-GEM ART-SYSTEMK904096PHOTAC-BOND

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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