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)

TEMREX-DENTIN VARNISH

K-Number: K851030 · 1985-06-20

ApplicantTemrex Corp.
Decision Date1985-06-20
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TEMREX-DENTIN VARNISH is the device name listed in this FDA 510(k) record. The listed applicant is Temrex Corp.. It received FDA 510(k) clearance on 1985-06-20 under 510(k) number K851030. 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 TEMREX-DENTIN VARNISH?

TEMREX-DENTIN VARNISH is a medical device that received FDA 510(k) clearance on 1985-06-20. The listed applicant is Temrex Corp.. The 510(k) number is K851030.

When did TEMREX-DENTIN VARNISH receive FDA 510(k) clearance?

TEMREX-DENTIN VARNISH received FDA 510(k) clearance on 1985-06-20, under 510(k) number K851030.

Who is the listed applicant for TEMREX-DENTIN VARNISH?

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

What is the FDA product code for TEMREX-DENTIN VARNISH?

The FDA product code for TEMREX-DENTIN VARNISH 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 Temrex Corp. 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.

K123273HOFFMANN'S CEMENT (PHOSPHATE, NORMAL)

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.

↑