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)

OJ-1 ENDODONIC ROOT CANAL FILE HOLDER

K-Number: K801463 · 1980-07-21

ApplicantAlmore Intl., Inc.
Decision Date1980-07-21
Product CodeEKQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OJ-1 ENDODONIC ROOT CANAL FILE HOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Almore Intl., Inc.. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K801463. 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 OJ-1 ENDODONIC ROOT CANAL FILE HOLDER?

OJ-1 ENDODONIC ROOT CANAL FILE HOLDER is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is Almore Intl., Inc.. The 510(k) number is K801463.

When did OJ-1 ENDODONIC ROOT CANAL FILE HOLDER receive FDA 510(k) clearance?

OJ-1 ENDODONIC ROOT CANAL FILE HOLDER received FDA 510(k) clearance on 1980-07-21, under 510(k) number K801463.

Who is the listed applicant for OJ-1 ENDODONIC ROOT CANAL FILE HOLDER?

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

What is the FDA product code for OJ-1 ENDODONIC ROOT CANAL FILE HOLDER?

The FDA product code for OJ-1 ENDODONIC ROOT CANAL FILE HOLDER 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 Almore Intl., 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.

K862851ALMORE FACE MASKK854692MONARCH II BLEACHING INSTRUMENTK854696OP II VISIBLE LIGHT CURING SYSTEMK854691DIAMOND BURS-HANDPIECEK854690DIAMONDS BURS-COMPOSIT FINISHINGK854700EZ-ON TUBING CONDITIONER (LUBRICANT)

View all 21 devices →

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.

K832378VIBRATORY ENDODONTIC SYSTEMSyntex Dental Products, 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.

↑