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FDA 510(k)

E-SARANG 86, DM78, DM55

K-Number: K033435 · 2003-11-12

ApplicantWe Dong Myung Dental Industrial Co., Ltd.
Decision Date2003-11-12
Product CodeEJT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

E-SARANG 86, DM78, DM55 is the device name listed in this FDA 510(k) record. The listed applicant is We Dong Myung Dental Industrial Co., Ltd.. It received FDA 510(k) clearance on 2003-11-12 under 510(k) number K033435. The device is classified under product code EJT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-SARANG 86, DM78, DM55?

E-SARANG 86, DM78, DM55 is a medical device that received FDA 510(k) clearance on 2003-11-12. The listed applicant is We Dong Myung Dental Industrial Co., Ltd.. The 510(k) number is K033435.

When did E-SARANG 86, DM78, DM55 receive FDA 510(k) clearance?

E-SARANG 86, DM78, DM55 received FDA 510(k) clearance on 2003-11-12, under 510(k) number K033435.

Who is the listed applicant for E-SARANG 86, DM78, DM55?

The FDA 510(k) record lists We Dong Myung Dental Industrial Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-SARANG 86, DM78, DM55?

The FDA product code for E-SARANG 86, DM78, DM55 is EJT.

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 We Dong Myung Dental Industrial Co., Ltd. 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.

K033446APEX93, APEX87, APEX84, APEX85, APEX77, E-SARANG 88 AND E-SARANG 82K033434BESTALOYK030206APEX 90

Related Devices (Code: EJT)

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.

K052463PROMETAL HN86Prometal TechnologiesK041378BIO 60Kodent, Inc.K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KGK040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KGK040043NDX-40 ALLOYHeraeus Kulzer, Inc.K034049HERADOR EC, PF, C, H, NH, G, GG AND MP; HERALOY U AND G; HERABOND N; ALBABOND C, B AND A; BIO HERANORMHeraeus Kulzer,GmbH

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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