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FDA 510(k)

DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50

K-Number: K991464 · 1999-07-20

ApplicantFisma, Inc.
Decision Date1999-07-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 is the device name listed in this FDA 510(k) record. The listed applicant is Fisma, Inc.. It received FDA 510(k) clearance on 1999-07-20 under 510(k) number K991464. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50?

DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 is a medical device that received FDA 510(k) clearance on 1999-07-20. The listed applicant is Fisma, Inc.. The 510(k) number is K991464.

When did DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 receive FDA 510(k) clearance?

DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 received FDA 510(k) clearance on 1999-07-20, under 510(k) number K991464.

Who is the listed applicant for DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50?

The FDA 510(k) record lists Fisma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50?

The FDA product code for DENTAL 200, DENTAL 300, DENTAL 400, MODELS E-20, E-60, E-50 is GEX. This falls under the Gastroenterology category.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Fisma, Inc. 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.

K000158VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9K990174ATLAS-ELITE,MODEL E-80,CORIUM 200,CORIUM 400, MODEL E-90, ELITE, MODEL E-80-II, ELITE ULTRA, MODEL E-80-IVK963124PC LASER WITH SMART PLUG (PC EDO & DENTAL 200)

Related Devices (Code: GEX)

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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