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FDA 510(k)

ICE

K-Number: K012528 · 2001-10-22

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

Device Summary

ICE 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 K012528. 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 ICE?

ICE 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 K012528.

When did ICE receive FDA 510(k) clearance?

ICE received FDA 510(k) clearance on 2001-10-22, under 510(k) number K012528.

Who is the listed applicant for ICE?

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 ICE?

The FDA product code for ICE 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: 42849513Surgical Artificial Intelligence Innovation Trends and Regulatory Insights: A Systematic Analysis of Food and Drug Administration-Approved Devices.Annals of surgery ()PMID: 42834824India's medical device regulatory framework: a decade of transformation, international harmonization, and the road to global competitiveness.Expert review of medical devices ()PMID: 42825233Medical Device Recalls in Neurosurgery: A United States Regulatory Analysis.Neurosurgery practice ()PMID: 42815842Biological-safety-by-design for bioresorbable intravascular drug-delivery implants: Operationalizing ISO 10993-1:2025 across device, degradation, and payload states.Regulatory toxicology and pharmacology : RTP ()

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.

K051008SETK012529ROK

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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