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)

VIBRATORY ENDODONTIC SYSTEM

K-Number: K832378 · 1983-10-04

ApplicantSyntex Dental Products, Inc.
Decision Date1983-10-04
Product CodeEKQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIBRATORY ENDODONTIC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Dental Products, Inc.. It received FDA 510(k) clearance on 1983-10-04 under 510(k) number K832378. The device is classified under product code EKQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIBRATORY ENDODONTIC SYSTEM?

VIBRATORY ENDODONTIC SYSTEM is a medical device that received FDA 510(k) clearance on 1983-10-04. The listed applicant is Syntex Dental Products, Inc.. The 510(k) number is K832378.

When did VIBRATORY ENDODONTIC SYSTEM receive FDA 510(k) clearance?

VIBRATORY ENDODONTIC SYSTEM received FDA 510(k) clearance on 1983-10-04, under 510(k) number K832378.

Who is the listed applicant for VIBRATORY ENDODONTIC SYSTEM?

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

What is the FDA product code for VIBRATORY ENDODONTIC SYSTEM?

The FDA product code for VIBRATORY ENDODONTIC SYSTEM is EKQ.

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 Syntex Dental Products, 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.

K823230STERILE WATER SYSTEMK822610PRECAPSULED DENTAL AMALGAM

Related Devices (Code: EKQ)

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.

K801463OJ-1 ENDODONIC ROOT CANAL FILE HOLDERAlmore Intl., 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.

↑