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)

J. MORITA FLEX M-3 TORX HARDPIECE

K-Number: K821739 · 1982-06-25

ApplicantPacific Dental Corp.
Decision Date1982-06-25
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

J. MORITA FLEX M-3 TORX HARDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Dental Corp.. It received FDA 510(k) clearance on 1982-06-25 under 510(k) number K821739. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the J. MORITA FLEX M-3 TORX HARDPIECE?

J. MORITA FLEX M-3 TORX HARDPIECE is a medical device that received FDA 510(k) clearance on 1982-06-25. The listed applicant is Pacific Dental Corp.. The 510(k) number is K821739.

When did J. MORITA FLEX M-3 TORX HARDPIECE receive FDA 510(k) clearance?

J. MORITA FLEX M-3 TORX HARDPIECE received FDA 510(k) clearance on 1982-06-25, under 510(k) number K821739.

Who is the listed applicant for J. MORITA FLEX M-3 TORX HARDPIECE?

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

What is the FDA product code for J. MORITA FLEX M-3 TORX HARDPIECE?

The FDA product code for J. MORITA FLEX M-3 TORX HARDPIECE is EKX.

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 Pacific Dental Corp. 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.

K821782BEACH ANESTHETIC SYRINGE CARTR. TYPEK821779BEACH AMALGAM CARRIER, GUN TYPEK821789BEACH CURETTE NO. 2 AND NO. 3 T.G.K821777BEACH MOUTH MIRRORK821778BEACH DRESSING PLIERK821780BEACH EXPLORER NO. 23T.G.

View all 22 devices →

Related Devices (Code: EKX)

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.

K261987Reusable SmartPegOsstell ABK252223Alpha Endo Handpiece (Alpha Endo)SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.K251597InnerView SystemPerimetrics, Inc.K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L.K242514Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)Shenzhen Rogin Medical Co., Ltd.K241065ChecQ (AC100)Dentis 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.

↑