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FDA 510(k)

NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES

K-Number: K971319 · 1997-05-22

ApplicantTycom Dental
Decision Date1997-05-22
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES is the device name listed in this FDA 510(k) record. The listed applicant is Tycom Dental. It received FDA 510(k) clearance on 1997-05-22 under 510(k) number K971319. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES?

NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES is a medical device that received FDA 510(k) clearance on 1997-05-22. The listed applicant is Tycom Dental. The 510(k) number is K971319.

When did NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES receive FDA 510(k) clearance?

NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES received FDA 510(k) clearance on 1997-05-22, under 510(k) number K971319.

Who is the listed applicant for NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES?

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

What is the FDA product code for NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES?

The FDA product code for NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILES is EKS.

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 Tycom Dental 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.

K962031QUANTEC SERIES 2000 ENDODONTIC FILES

Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.K935542NICKEL-TITANIUM K-TYPE FILEUnion Broach, Div. Moyco Industries, Inc.

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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