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)

DENTAL INSTRUMENTS - KNIVES

K-Number: K823315 · 1982-11-24

ApplicantMiltex, Inc.
Decision Date1982-11-24
Product CodeEJZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DENTAL INSTRUMENTS - KNIVES is the device name listed in this FDA 510(k) record. The listed applicant is Miltex, Inc.. It received FDA 510(k) clearance on 1982-11-24 under 510(k) number K823315. The device is classified under product code EJZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENTAL INSTRUMENTS - KNIVES?

DENTAL INSTRUMENTS - KNIVES is a medical device that received FDA 510(k) clearance on 1982-11-24. The listed applicant is Miltex, Inc.. The 510(k) number is K823315.

When did DENTAL INSTRUMENTS - KNIVES receive FDA 510(k) clearance?

DENTAL INSTRUMENTS - KNIVES received FDA 510(k) clearance on 1982-11-24, under 510(k) number K823315.

Who is the listed applicant for DENTAL INSTRUMENTS - KNIVES?

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

What is the FDA product code for DENTAL INSTRUMENTS - KNIVES?

The FDA product code for DENTAL INSTRUMENTS - KNIVES is EJZ.

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 Miltex, 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.

K101653MILTEX THOMPSON CASSETTES; MILTEX SURGICAL CASSETTESK092855MILTEX MEMBRANE TACK KITK083796MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHTK072563MILTEX RIGID CONTAINER SYSTEMSK061033MILTEX RIGID STERILIZATION CONTAINER SYSTEM, (47 COMPONENTS)K052018MILTEX LIGATING CLIP

View all 23 devices →

Related Devices (Code: EJZ)

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.

K872622ORTHODONTIC ARCHWonder Wire

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.

↑