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)

EUROCART SR-4, EUROCART M-IV, ISOCART III

K-Number: K863010 · 1986-09-26

ApplicantSds Dental, Inc.
Decision Date1986-09-26
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EUROCART SR-4, EUROCART M-IV, ISOCART III is the device name listed in this FDA 510(k) record. The listed applicant is Sds Dental, Inc.. It received FDA 510(k) clearance on 1986-09-26 under 510(k) number K863010. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EUROCART SR-4, EUROCART M-IV, ISOCART III?

EUROCART SR-4, EUROCART M-IV, ISOCART III is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Sds Dental, Inc.. The 510(k) number is K863010.

When did EUROCART SR-4, EUROCART M-IV, ISOCART III receive FDA 510(k) clearance?

EUROCART SR-4, EUROCART M-IV, ISOCART III received FDA 510(k) clearance on 1986-09-26, under 510(k) number K863010.

Who is the listed applicant for EUROCART SR-4, EUROCART M-IV, ISOCART III?

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

What is the FDA product code for EUROCART SR-4, EUROCART M-IV, ISOCART III?

The FDA product code for EUROCART SR-4, EUROCART M-IV, ISOCART III is EIA.

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 Sds Dental, 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.

K990546DELSONIC 2000K990545JETSONIC 2000K964619DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS1450,SDS1650 XL)K902865BAUMER SURGICAL TABLEK902864SURGICAL LIGHTING-CENTRA 450K863011DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II

View all 21 devices →

Related Devices (Code: EIA)

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.

K251544Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)Lakong Medical Devices Co., Ltd.K251626Midmark Dental Delivery SystemMidmark CorporationK251491K5 Cart, K5 Mount, K5 SwingOsstem Implant Company., Ltd. Chair BusinessK243130Integral Dental UnitGuangdong Yadeng Medical Apparatus Co., Ltd.,K242611Integral Dental UnitsMipont Medical Equipment Co., Ltd.K250473Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusDci International, 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.

↑