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)

BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT

K-Number: K101849 · 2010-10-01

ApplicantBicon, LLC
Decision Date2010-10-01
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Bicon, LLC. It received FDA 510(k) clearance on 2010-10-01 under 510(k) number K101849. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT?

BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT is a medical device that received FDA 510(k) clearance on 2010-10-01. The listed applicant is Bicon, LLC. The 510(k) number is K101849.

When did BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT receive FDA 510(k) clearance?

BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT received FDA 510(k) clearance on 2010-10-01, under 510(k) number K101849.

Who is the listed applicant for BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT?

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

What is the FDA product code for BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT?

The FDA product code for BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT is DZE.

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 Bicon, LLC 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.

K092035BICON IMPLANTS WITH A 2.5MM INTERNAL CONNECTIONK0733685.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, 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.

↑