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)

TDS ABUTMENT FOR NOBEL BIOCARE REPLACE

K-Number: K091026 · 2009-06-24

ApplicantPou YU Biotechnology Co., Ltd.
Decision Date2009-06-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TDS ABUTMENT FOR NOBEL BIOCARE REPLACE is the device name listed in this FDA 510(k) record. The listed applicant is Pou YU Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2009-06-24 under 510(k) number K091026. 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 TDS ABUTMENT FOR NOBEL BIOCARE REPLACE?

TDS ABUTMENT FOR NOBEL BIOCARE REPLACE is a medical device that received FDA 510(k) clearance on 2009-06-24. The listed applicant is Pou YU Biotechnology Co., Ltd.. The 510(k) number is K091026.

When did TDS ABUTMENT FOR NOBEL BIOCARE REPLACE receive FDA 510(k) clearance?

TDS ABUTMENT FOR NOBEL BIOCARE REPLACE received FDA 510(k) clearance on 2009-06-24, under 510(k) number K091026.

Who is the listed applicant for TDS ABUTMENT FOR NOBEL BIOCARE REPLACE?

The FDA 510(k) record lists Pou YU Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TDS ABUTMENT FOR NOBEL BIOCARE REPLACE?

The FDA product code for TDS ABUTMENT FOR NOBEL BIOCARE REPLACE 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 Pou YU Biotechnology Co., Ltd. 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.

K103339TDS ABUTMENT FOR FRIADENT XIVEK100356TDS PRECISION DENTAL BARK091392TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARKK091693TDS ZIRCONIA ABUTMENT FOR NOBEL BIOCARE BRANEMARKK081460TDS ABUTMENT

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.

↑