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)

SUPER SEAL TOOTH DESENSITIZER

K-Number: K120109 · 2012-03-07

ApplicantPhoenix Dental, Inc.
Decision Date2012-03-07
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SUPER SEAL TOOTH DESENSITIZER 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 2012-03-07 under 510(k) number K120109. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPER SEAL TOOTH DESENSITIZER?

SUPER SEAL TOOTH DESENSITIZER is a medical device that received FDA 510(k) clearance on 2012-03-07. The listed applicant is Phoenix Dental, Inc.. The 510(k) number is K120109.

When did SUPER SEAL TOOTH DESENSITIZER receive FDA 510(k) clearance?

SUPER SEAL TOOTH DESENSITIZER received FDA 510(k) clearance on 2012-03-07, under 510(k) number K120109.

Who is the listed applicant for SUPER SEAL TOOTH DESENSITIZER?

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 SUPER SEAL TOOTH DESENSITIZER?

The FDA product code for SUPER SEAL TOOTH DESENSITIZER is LBH.

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.

K102821DISCOVREDK983477SUPER SEALK926101PHOENIX OPTI-MAX DENT IMPL W/PLAS-SPRAY TITA/HYDROK926102PHOENIX OPTI-MAX DENT IMPLANT W/PLASMA-SPRAY TITAN

Related Devices (Code: LBH)

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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, 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.

↑