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FDA 510(k)

JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS

K-Number: K802988 · 1980-12-30

ApplicantSwiss American Metal Craft Corp.
Decision Date1980-12-30
Product CodeEJL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS is the device name listed in this FDA 510(k) record. The listed applicant is Swiss American Metal Craft Corp.. It received FDA 510(k) clearance on 1980-12-30 under 510(k) number K802988. The device is classified under product code EJL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS?

JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS is a medical device that received FDA 510(k) clearance on 1980-12-30. The listed applicant is Swiss American Metal Craft Corp.. The 510(k) number is K802988.

When did JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS receive FDA 510(k) clearance?

JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS received FDA 510(k) clearance on 1980-12-30, under 510(k) number K802988.

Who is the listed applicant for JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS?

The FDA 510(k) record lists Swiss American Metal Craft Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS?

The FDA product code for JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS is EJL.

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 Swiss American Metal Craft 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.

K802989MEISINGER TUNGSTEN CARBIDE & STEEL DT.B.K802984MEISINGER DIAMOND DENTAL BURSK802987JOTA DIAMOND DENTAL BURS

Related Devices (Code: EJL)

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.

K080687SMARTBURSS.S. White Burs, Inc.K071352CERADRILLGebr. Brasseler GmbH & Co. KGK061383BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPSB.T.I. Biotechnology Institute, Sl.K943273TRI HAWK BUR, FG BURTri Hawk Corp.K926205MONOSTERYLUtensili Super AbrasiviK923883DENTAL OR SURGICAL BURStratum Dental Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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