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)

PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN

K-Number: K926102 · 1994-06-22

ApplicantPhoenix Dental, Inc.
Decision Date1994-06-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Dental, Inc.. It received FDA 510(k) clearance on 1994-06-22 under 510(k) number K926102. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN?

PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN is a medical device that received FDA 510(k) clearance on 1994-06-22. The listed applicant is Phoenix Dental, Inc.. The 510(k) number is K926102.

When did PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN receive FDA 510(k) clearance?

PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN received FDA 510(k) clearance on 1994-06-22, under 510(k) number K926102.

Who is the listed applicant for PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN?

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

What is the FDA product code for PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN?

The FDA product code for PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN is DZE.

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 Phoenix Dental, 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.

K120109SUPER SEAL TOOTH DESENSITIZERK102821DISCOVREDK983477SUPER SEALK926101PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.

↑