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)

NICKEL-TITANIUM K-TYPE FILE

K-Number: K935542 · 1994-01-03

ApplicantUnion Broach, Div. Moyco Industries, Inc.
Decision Date1994-01-03
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NICKEL-TITANIUM K-TYPE FILE is the device name listed in this FDA 510(k) record. The listed applicant is Union Broach, Div. Moyco Industries, Inc.. It received FDA 510(k) clearance on 1994-01-03 under 510(k) number K935542. 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 NICKEL-TITANIUM K-TYPE FILE?

NICKEL-TITANIUM K-TYPE FILE is a medical device that received FDA 510(k) clearance on 1994-01-03. The listed applicant is Union Broach, Div. Moyco Industries, Inc.. The 510(k) number is K935542.

When did NICKEL-TITANIUM K-TYPE FILE receive FDA 510(k) clearance?

NICKEL-TITANIUM K-TYPE FILE received FDA 510(k) clearance on 1994-01-03, under 510(k) number K935542.

Who is the listed applicant for NICKEL-TITANIUM K-TYPE FILE?

The FDA 510(k) record lists Union Broach, Div. Moyco Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NICKEL-TITANIUM K-TYPE FILE?

The FDA product code for NICKEL-TITANIUM K-TYPE FILE 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 Union Broach, Div. Moyco Industries, 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.

K962733CYBER-FIL ALKENOATE CEMENT MULTI-PURPOSE KIT (23900/23905/23910/23915/23920)K950365MOYCO-EDTAK941574RETRO MIRRORK940260THERMAL PULP TESTERK931742INJECT-R FILLK923661QUADRASORB FILTER

View all 14 devices →

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.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, 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.

↑