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)

FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502

K-Number: K051750 · 2005-09-19

ApplicantUltradent Products, Inc.
Decision Date2005-09-19
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Products, Inc.. It received FDA 510(k) clearance on 2005-09-19 under 510(k) number K051750. 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 FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502?

FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 is a medical device that received FDA 510(k) clearance on 2005-09-19. The listed applicant is Ultradent Products, Inc.. The 510(k) number is K051750.

When did FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 receive FDA 510(k) clearance?

FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 received FDA 510(k) clearance on 2005-09-19, under 510(k) number K051750.

Who is the listed applicant for FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502?

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

What is the FDA product code for FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502?

The FDA product code for FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 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 Ultradent Products, 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.

K262228Transcend Bulk Fill Flowable CompositeK261404UltraEZK240743Peak Universal BondK240694FORMA Composite (Shade A3D)K221909J-TempK220471VALO X, VALO X Accessory Lenses

View all 102 devices →

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.

↑