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FDA 510(k)

ECO/DENTAL GENERAL DENTAL PACK

K-Number: K922988 · 1992-11-04

ApplicantDyna-Pace Systems, Inc.
Decision Date1992-11-04
Product CodeEKJ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ECO/DENTAL GENERAL DENTAL PACK is the device name listed in this FDA 510(k) record. The listed applicant is Dyna-Pace Systems, Inc.. It received FDA 510(k) clearance on 1992-11-04 under 510(k) number K922988. The device is classified under product code EKJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECO/DENTAL GENERAL DENTAL PACK?

ECO/DENTAL GENERAL DENTAL PACK is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Dyna-Pace Systems, Inc.. The 510(k) number is K922988.

When did ECO/DENTAL GENERAL DENTAL PACK receive FDA 510(k) clearance?

ECO/DENTAL GENERAL DENTAL PACK received FDA 510(k) clearance on 1992-11-04, under 510(k) number K922988.

Who is the listed applicant for ECO/DENTAL GENERAL DENTAL PACK?

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

What is the FDA product code for ECO/DENTAL GENERAL DENTAL PACK?

The FDA product code for ECO/DENTAL GENERAL DENTAL PACK is EKJ.

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

Related Devices (Code: EKJ)

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.

K961714ASEPTYLUM, UNI-CARRIERDistriflor S.A.K953707MEDTROL DENTAL KITMedtrol, Inc.K945815DENTAL KITConstancy Ent., Inc.K951607SUREFLEX FILESDentsply Intl.K945077INSTRUMENT,FILLING,PLASTIC,DENTALWorldwide Dental, Inc.K943820STAT PAKMagnum Instruments, 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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