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)

PACIFIC IMPLANT TITANIUM ENDODONTIC POINT

K-Number: K992582 · 1999-10-21

ApplicantPacific Implant, Inc.
Decision Date1999-10-21
Product CodeEKL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PACIFIC IMPLANT TITANIUM ENDODONTIC POINT is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Implant, Inc.. It received FDA 510(k) clearance on 1999-10-21 under 510(k) number K992582. The device is classified under product code EKL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACIFIC IMPLANT TITANIUM ENDODONTIC POINT?

PACIFIC IMPLANT TITANIUM ENDODONTIC POINT is a medical device that received FDA 510(k) clearance on 1999-10-21. The listed applicant is Pacific Implant, Inc.. The 510(k) number is K992582.

When did PACIFIC IMPLANT TITANIUM ENDODONTIC POINT receive FDA 510(k) clearance?

PACIFIC IMPLANT TITANIUM ENDODONTIC POINT received FDA 510(k) clearance on 1999-10-21, under 510(k) number K992582.

Who is the listed applicant for PACIFIC IMPLANT TITANIUM ENDODONTIC POINT?

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

What is the FDA product code for PACIFIC IMPLANT TITANIUM ENDODONTIC POINT?

The FDA product code for PACIFIC IMPLANT TITANIUM ENDODONTIC POINT is EKL.

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 Pacific Implant, 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.

K813227INTRAOSSEOUS DENTAL IMPLANT

Related Devices (Code: EKL)

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.

K961089PULPDENT ENDOPREP IIPulpdent Corp.K822568EAR PROBESKelleher Corp.

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.

↑