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 IMPL W/PLAS-SPRAY TITA/HYDRO

K-Number: K926101 · 1994-06-23

Decision Date1994-06-23
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO 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 1994-06-23 under 510(k) number K926101. 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 IMPL W/PLAS-SPRAY TITA/HYDRO?

PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO is a medical device that received FDA 510(k) clearance on 1994-06-23. The listed applicant is Phoenix Dental, Inc.. The 510(k) number is K926101.

When did PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO receive FDA 510(k) clearance?

PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO received FDA 510(k) clearance on 1994-06-23, under 510(k) number K926101.

Who is the listed applicant for PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO?

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 IMPL W/PLAS-SPRAY TITA/HYDRO?

The FDA product code for PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDRO 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.

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.

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.

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.

↑