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)

TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES

K-Number: K854168 · 1986-03-13

ApplicantTravenol Laboratories, S.A.
Decision Date1986-03-13
Product CodeELA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1986-03-13 under 510(k) number K854168. The device is classified under product code ELA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES?

TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES is a medical device that received FDA 510(k) clearance on 1986-03-13. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K854168.

When did TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES receive FDA 510(k) clearance?

TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES received FDA 510(k) clearance on 1986-03-13, under 510(k) number K854168.

Who is the listed applicant for TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES?

The FDA product code for TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES is ELA.

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 Travenol Laboratories, S.A. 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.

K874181BAXTER BEDSIDE SYSTEMK873894CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITEK873873RESUBMITTED MICRON TRANSFUSION FILTERK873984AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437)K872364HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309K872652UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM

View all 206 devices →

Related Devices (Code: ELA)

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.

K952363OPUS PACEMAKERS (MODELS 4021, 4033, AND 4034)Ela Medical, Inc.K823326DENTAL INSTRUMENTS - CUTTING INSTRUMENTMiltex, Inc.K801974ANALYTIC TECH. METAL POINT HEATER #3001Analytic Technology

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.

↑