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FDA 510(k)

LITEX 680

K-Number: K955759 · 1996-01-02

ApplicantDentamerica
Decision Date1996-01-02
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LITEX 680 is the device name listed in this FDA 510(k) record. The listed applicant is Dentamerica. It received FDA 510(k) clearance on 1996-01-02 under 510(k) number K955759. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITEX 680?

LITEX 680 is a medical device that received FDA 510(k) clearance on 1996-01-02. The listed applicant is Dentamerica. The 510(k) number is K955759.

When did LITEX 680 receive FDA 510(k) clearance?

LITEX 680 received FDA 510(k) clearance on 1996-01-02, under 510(k) number K955759.

Who is the listed applicant for LITEX 680?

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

What is the FDA product code for LITEX 680?

The FDA product code for LITEX 680 is EBZ.

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 Dentamerica 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.

K092833ENDOMAX CORDLESS ENDODONTIC HANDPIECEK060640DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEMK954820SCALEX 800

Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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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