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FDA 510(k)

ROK

K-Number: K012529 · 2001-10-22

ApplicantSouthern Dental Industries, Ltd.
Decision Date2001-10-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROK is the device name listed in this FDA 510(k) record. The listed applicant is Southern Dental Industries, Ltd.. It received FDA 510(k) clearance on 2001-10-22 under 510(k) number K012529. 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 ROK?

ROK is a medical device that received FDA 510(k) clearance on 2001-10-22. The listed applicant is Southern Dental Industries, Ltd.. The 510(k) number is K012529.

When did ROK receive FDA 510(k) clearance?

ROK received FDA 510(k) clearance on 2001-10-22, under 510(k) number K012529.

Who is the listed applicant for ROK?

The FDA 510(k) record lists Southern Dental Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROK?

The FDA product code for ROK is EBF.

Related PubMed Literature

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.

PMID: 41502788Translational Evaluation of a Machine Learning-Based Interactive Lab for Aphasia Rehabilitation in Post Stroke Patients.IEEE journal of translational engineering in health and medicine ()PMID: 34785618Food and Drug Association Approval Process for Devices Used in Endovascular Treatment of Stroke.Neurology ()PMID: 29988408Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke.Frontiers in neurology ()

Other records listing Southern Dental Industries, Ltd. 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.

K051008SETK012528ICE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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