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)

QUELL DESENSITIZER

K-Number: K010957 · 2001-06-25

ApplicantJeneric/Pentron, Inc.
Decision Date2001-06-25
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

QUELL DESENSITIZER is the device name listed in this FDA 510(k) record. The listed applicant is Jeneric/Pentron, Inc.. It received FDA 510(k) clearance on 2001-06-25 under 510(k) number K010957. 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 QUELL DESENSITIZER?

QUELL DESENSITIZER is a medical device that received FDA 510(k) clearance on 2001-06-25. The listed applicant is Jeneric/Pentron, Inc.. The 510(k) number is K010957.

When did QUELL DESENSITIZER receive FDA 510(k) clearance?

QUELL DESENSITIZER received FDA 510(k) clearance on 2001-06-25, under 510(k) number K010957.

Who is the listed applicant for QUELL DESENSITIZER?

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

What is the FDA product code for QUELL DESENSITIZER?

The FDA product code for QUELL 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 Jeneric/Pentron, 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.

K020499BOND-3 ADHESIVEK013543BOND-1 C & BK013542DENTIN CONDITIONING AND ADHESIVE SYSTEM (BOND-1)K012231AVANTE MICRO CRYSTAL SYSTEMK011748FIRST FILL R.C.S.K011331JP CAST 40

View all 78 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.

↑