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)

BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS

K-Number: K122559 · 2013-05-03

ApplicantBiodenta Swiss AG
Decision Date2013-05-03
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Biodenta Swiss AG. It received FDA 510(k) clearance on 2013-05-03 under 510(k) number K122559. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS?

BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS is a medical device that received FDA 510(k) clearance on 2013-05-03. The listed applicant is Biodenta Swiss AG. The 510(k) number is K122559.

When did BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS receive FDA 510(k) clearance?

BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS received FDA 510(k) clearance on 2013-05-03, under 510(k) number K122559.

Who is the listed applicant for BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS?

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

What is the FDA product code for BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS?

The FDA product code for BIODENTA DENTAL IMPLANT SYSTEM - ABUTMENTS is NHA.

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 Biodenta Swiss AG 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.

K123491BIODENTA DENTAL IMPLANT SYSTEM - MULTI-USE ABUTMENTK123512BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL D 3.0 TO 6.0 MMK123415BIODENTA DENTAL IMPLANT SYSTEM- BONE LEVEL TAPEREDK111003BIODENTA DENTAL IMPLANT SYSTEM - BONE LEVELK110778BIODENTA CUSTOMIZED ABUTMENTK093630BIODENTA DENTAL IMPLANT SYSTEM

View all 8 devices →

Related Devices (Code: NHA)

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.

K262207Cemented Plus AbutmentUnidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, 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.

↑