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)

ADHESIVE 14

K-Number: K022973 · 2002-11-22

ApplicantAb Ardent
Decision Date2002-11-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADHESIVE 14 is the device name listed in this FDA 510(k) record. The listed applicant is Ab Ardent. It received FDA 510(k) clearance on 2002-11-22 under 510(k) number K022973. 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 ADHESIVE 14?

ADHESIVE 14 is a medical device that received FDA 510(k) clearance on 2002-11-22. The listed applicant is Ab Ardent. The 510(k) number is K022973.

When did ADHESIVE 14 receive FDA 510(k) clearance?

ADHESIVE 14 received FDA 510(k) clearance on 2002-11-22, under 510(k) number K022973.

Who is the listed applicant for ADHESIVE 14?

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

What is the FDA product code for ADHESIVE 14?

The FDA product code for ADHESIVE 14 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 Ab Ardent 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.

K131753MERIDIANK040465LATIT FLOWK022971MICROHYBRID 11K022972MICROFILL 13K022975ETCHING 15K022974MICROHYBRID 12

View all 13 devices →

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.

↑