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)

B1P ADHESIVE

K-Number: K111431 · 2011-08-01

ApplicantPentron Clinical
Decision Date2011-08-01
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

B1P ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is Pentron Clinical. It received FDA 510(k) clearance on 2011-08-01 under 510(k) number K111431. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the B1P ADHESIVE?

B1P ADHESIVE is a medical device that received FDA 510(k) clearance on 2011-08-01. The listed applicant is Pentron Clinical. The 510(k) number is K111431.

When did B1P ADHESIVE receive FDA 510(k) clearance?

B1P ADHESIVE received FDA 510(k) clearance on 2011-08-01, under 510(k) number K111431.

Who is the listed applicant for B1P ADHESIVE?

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

What is the FDA product code for B1P ADHESIVE?

The FDA product code for B1P ADHESIVE is KLE.

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 Pentron Clinical 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.

K130920CORRECT PLUS 1K120013TEMPSPAN CLEAR MATRIXK102703BUILD-IT TOTAL CORE

Related Devices (Code: KLE)

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.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

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.

↑