Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

INFIMED DENTAL SYSTEM

K-Number: K962422 · 1997-09-11

ApplicantInfimed, Inc.
Decision Date1997-09-11
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

INFIMED DENTAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Infimed, Inc.. It received FDA 510(k) clearance on 1997-09-11 under 510(k) number K962422. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFIMED DENTAL SYSTEM?

INFIMED DENTAL SYSTEM is a medical device that received FDA 510(k) clearance on 1997-09-11. The listed applicant is Infimed, Inc.. The 510(k) number is K962422.

When did INFIMED DENTAL SYSTEM receive FDA 510(k) clearance?

INFIMED DENTAL SYSTEM received FDA 510(k) clearance on 1997-09-11, under 510(k) number K962422.

Who is the listed applicant for INFIMED DENTAL SYSTEM?

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

What is the FDA product code for INFIMED DENTAL SYSTEM?

The FDA product code for INFIMED DENTAL SYSTEM is EHD.

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 Infimed, 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.

K112180I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)K111344I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)K103416NEXUS DRF DIGITAL X-RAY IMAGING SYSTEMK101833INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5K093066I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5K012490ORION DIGITAL IMAGING SYSTEM

View all 14 devices →

Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument Co., Ltd.

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.

↑